Ignite Creation Date:
2024-05-06 @ 9:16 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02942056
Status:
WITHDRAWN
Last Update Posted:
2019-08-06
First Post:
2016-10-20
Brief Title:
The Effect of Cinnamon Cassia on Diabetes Control and Cardiometabolic Risk Factors in Adults With Type 2 Diabetes Mellitus
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
The Effect of Cinnamon Cassia on Diabetes Control and Cardiometabolic Risk Factors in Adults With Type 2 Diabetes Mellitus
Status:
WITHDRAWN
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Could not obtain appropriate funding or standardized manufacturing for cinnamon tablets
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall goal of this proposal is to establish the efficacy of cinnamon for the treatment of T2DM Additional aims will assess the effect of cinnamon on cardiovascular risk factors and explore novel potential mechanisms of action leading to improved insulin sensitivity Based on previously published animal and human data we have hypothesized that six months treatment with Cinnamon cassia supplementation 225 gramsday will improve glycemic control and cardio-metabolic risk factors We believe these benefits may be mediated in part through improved insulin mediated capillary recruitment and skeletal muscle vasodilators leading to reduced insulin resistance We will achieve our goal through completion of the following aims
Aim 1 To demonstrate the efficacy safety and tolerability of oral cinnamon use 750 mg three times daily to improve glucose control The primary outcome will be determined as a reduction in hemglobin A1c HbA1c level of at least 05 compared to placebo
Aim 2 To quantify effects of oral cinnamon vs placebo on cardio-metabolic risk factors including fasting levels of plasma insulin and glucose homeostatic model assessment of insulin resistance HOMA-IR lipids total VLDL LDL HDL cholesterol triglyceride free fatty acids as well whole body abdominal and visceral adiposity as measured with dual energy x-ray absorptiometry DEXA imaging
Aim 3 In this mechanistic exploratory aim potential gastrointesitnal effects will be assessed as follows a 3-hour oral glucose tolerance test OGTT with blood samples collected for insulin glucose C-peptide glucagon GLP-1 and GIP will be performed separately Additional biochemical markers ghrelin PYY pro-insulin apo B adinopectin will be collected as well
Aim 1 To demonstrate the efficacy safety and tolerability of oral cinnamon use 750 mg three times daily to improve glucose control The primary outcome will be determined as a reduction in hemglobin A1c HbA1c level of at least 05 compared to placebo
Aim 2 To quantify effects of oral cinnamon vs placebo on cardio-metabolic risk factors including fasting levels of plasma insulin and glucose homeostatic model assessment of insulin resistance HOMA-IR lipids total VLDL LDL HDL cholesterol triglyceride free fatty acids as well whole body abdominal and visceral adiposity as measured with dual energy x-ray absorptiometry DEXA imaging
Aim 3 In this mechanistic exploratory aim potential gastrointesitnal effects will be assessed as follows a 3-hour oral glucose tolerance test OGTT with blood samples collected for insulin glucose C-peptide glucagon GLP-1 and GIP will be performed separately Additional biochemical markers ghrelin PYY pro-insulin apo B adinopectin will be collected as well
Detailed Description:
Experimental Design
This Phase 2 study will be done prospectively and will be conducted in two stages The initial stage will be the general study and the second stage will be the sub-study We plan to screen up to 1000 subjects Our enrollment goal is 250 subjects total with 50 subjects enrolled in the sub-study and 200 subjects enrolled in the general study
Adults will be screened from Oregon Health Science University clinics cardiology internal medicine endocrinology obstetrics and gynecology family practice through Epic-based database searches and research flyer distribution At OHSU the Research Data Warehouse RDW will be used to identify potential subjects and recruitment letters will be sent out Additional advertisement will be conducted through March Wellness and the medical exercise program Further outreach advertising will be done through the Oregon Association of Naturopathic Physicians OANP website and the Naturopathic Doctor News Reviews NDNR newsletter
We will not include any vulnerable populations We will not recruit prisoners children neonates andor adults lacking capacity
In the event of a screen failure the data collected in screening will be retained to avoid future re-contacting for recruitment for this study The data will be handled in a confidential manner until destroyed at the end of enrollment
InclusionExclusion Criteria
Recruited subjects will meet the following criteria
Inclusion Criteria
Males and females ages 30-65 years of age
Diagnosed Type 2 diabetes with a HbA1c of 65-9 treated with either lifestyle alone or with metformin
Weight stable for 3 months as defined by no greater than a 5 change
Exclusion Criteria
Pregnancy
Breast feeding
Use of any other diabetes treatment other than metformin within the past 3 months
Type 1 diabetes
HbA1c 9 or less than 65
Liver disease with a known diagnosis of cirrhosis
Liver Dysfunction with AST or ALT liver enzymes 2x upper limit of normal
Chronic Kidney Disease with glomerular filtration rate 45 mlmin173m2
Anemia with hematocrit 30
TSH 5 or 04 mIUL
Coagulopathy INR 13
Use of warfarin or other new oral anticoagulants dabigatran rivaroxaban apixaban
Use of subcutaneous heparin enoxaparin dalteparin
Use of class 1 or class 3 anti-arrhythmic medications disopyramide procainamide quinidine mexilitine flecanide propafenone amiodarone sotalol dronedarone dofetilide
Use of immunosuppressants methotrexate prednisone tacrolimus sirolimus azathioprine mycophenolate cyclosporine
Chronic use of benzodiazepines midazolam alprazolam lorezepam temezepam diazepam clonazepam chlordiazepoxide for the past 3 months
Chronic use of medications that may affect body weight glucose or lipid metabolism eg anti-psychotics anti-seizure weight loss meds for the past 3 months
Patients with celiac sprue or gluten sensitive individuals
Self-report of 3 alcoholic drinks per day
Congestive heart failure ejection fraction 45
Known hypersensitivity to Definity ultrasound contrast agent for sub-study
Intra-cardiac or pulmonary shunt
Screening Visit
After receiving a verbal and graphical summary of the study subjects may opt into the General Study or a more detailed Mechanistic Sub-Study See below
Baseline Visit and Week 6 to 24 Study Visits in the General Study
Once subjects are screened those that have consented and are enrolled in the General Study will undergo the following tests and procedures
1 For women of child bearing potential a urine pregnancy test will be performed This must be done prior to iDEXA scan and should be done prior to randomization
2 Complete chemistry panel for liver and kidney function fasting insulin complete blood count CBC fasting lipid panel urine analysis and iDEXA scan for body composition Subject must be fasting for 8 hours Any remaining blood samples after being used for this study will be stored in the repository
3 Subjects will have an Actical monitor fit to their waist to wear for one week
4 24 hour food recalls will be performed by study staff The recalls will be conducted over the phone three separate times within 14-21 days at baseline and at 24 weeks
5 Prior to baseline visit discharge subjects will be randomized in a double blinded fashion in a 11 ratio to either 750 mg of cinnamon cassia or placebo three times daily for 24 weeks
6 Pills will be picked up and empty bottles returned for pill count by study staff at every visit
7 After 6 weeks of treatment subjects will have blood and urine testing for safety monitoring liver function tests CBC and urine analysis
8 After 12 weeks of treatment an HbA1c fasting insulin and fasting lipid panel will be drawn for an interim analysis Repeat safety profile with a complete chemistry panel for liver and kidney function and CBC will also be obtained Subject must be fasting for 8 hours
9 After 24 weeks of therapy subjects will return for a final visit in which all baseline tests and procedures will be repeated blood draw urine test iDEXA Actical food recalls
10 Adverse events and concomitant medications will be reviewed
11 Baseline visit will occur 10 5 days from the screening visit
12 All follow-up visits Weeks 6-24 will be done 7 days
Baseline Visit and Week 6 to 24 Study Visits in the Sub-Study
Those subjects that have consented and are enrolled in the Mechanistic Sub-Study will undergo the following baseline tests and procedures
On Day 1 of baseline testing the following tests will be performed
1 For women of child bearing potential a urine pregnancy test will be performed This must be done prior to iDEXA scan and should be done prior to randomization
2 Complete chemistry panel for liver and kidney function fasting insulin CBC fasting lipid panel HbA1c urine analysis and iDEXA scan for body composition Any remaining blood samples after being used for this study will be stored in the repository
On Day 2 of baseline testing within 1 week of Day 1 the following tests will be performed
1 Oral glucose tolerance test with a plasma sample obtained just prior to and after glucose ingestion for GI secretory function analysis
2 Subjects will have an Actical activity monitor fit to their waist to wear for a week
3 24 hour food recalls will be scheduled and performed by study staff
Following completion of these baseline studies subjects will be randomized in a double blinded fashion in a 11 ratio to either 750 mg of cinnamon cassia or placebo three times daily for 24 weeks
At the 6 and 18 week visit the following tests will be performed blood draw will be for safety with LFTs CBC and Urinalysis
At the 12 week visit the following tests and procedures will be performed
1 Subjects will be admitted to the CTRC for active metabolite testing
2 Subjects will have blood testing for safety monitoring complete chemistry panel with LFTs CBC and urinalysis and an HbA1c fasting insulin and fasting lipid panel drawn for an interim analysis
After 24 weeks of therapy subjects will return for a final visit in which all baseline tests will be repeated
Methods
All Methods below are research related inquiries
Dual X-Ray Absorptiometry DEXA Body composition total lean and fat mass and skeletal mineral content and body fat distribution will be measured by a trained technician in OHSUs Body Energy and Composition Core using a GE Healthcare Lunar iDEXA with encore software Pregnancy testing will be performed in all women prior to each total body scan If the results are positive the participant will be withdrawn from the study and referred to her personal health care provider
OGTT Following an overnight fast subjects will have an IV placed in an antecubital fossa After at least 15 minutes of rest three baseline samples will be obtained and the subject will then ingest 75 gm of glucose Blood for glucose insulin C-peptide glucagon GLP-1 and GIP will be obtained at times -15 -10 -5 015 30 60 90 120 and 180 minutes Proinsulin will be measured in one of the baseline samples Insulin sensitivity will be estimated using the Insulin Sensitivity Index 10000square root of fasting glucose x fasting insulin x mean glucose x mean insulin during OGTT 22 Insulin secretion capacity will be estimated using the Insulinogenic Index insulinogenic index delta area under the curve AUC insulin delta AUC glucose 23
Plasma Chemistries Total lipids total VLDL LDL and HDL cholesterol triglycerides and apolipoprotein B will be measured by the OHSU Lipid Lab Complete chemistry panel urine analysis HbA1C TSH and CBC will be performed through the OHSU Core Laboratory Insulin glucose C-peptide glucagon GLP-1 GIP ghrelin PYY pro-insulin apo B and adiponectin will be measured in the OCTRI Core Laboratory
24-Hour Diet Recall A series of three 24-hour food recall interviews will be done by telephone by trained OCTRI Bionutrition Unit staff to determine nutrient intake The recalls will be conducted over the phone three separate times within 14-21 days at baseline and at 6 months The series of three calls will occur once before the beginning of the intervention phase and again during the last week of Intervention 6 months to ensure to the extent possible that diet habits have been maintained The recalls will be unannounced and unscheduled so that participants are unlikely to change their normal eating habits All interviewers will have completed a training program and met qualification standards established in the OCTRI Bionutrition Unit and based on Nutrition Data System for Research NDSR NDSR is a computer based software application developed at the University of Minnesota Nutrition Coordinating Center NCC that facilitates the collection of recalls in a standardized fashion 19 Dietary intake data gathered by interview is governed by a multiple-pass interview approach 20 Four distinct passes provide multiple opportunities for the participant to recall food intake The first pass involves obtaining from the participant a listing of all foods and beverages consumed in the previous 24 hours This listing is reviewed with the participant for completeness and correctness second pass The interviewer then collects detailed information about each reported food and beverage including the amount consumed and method of preparation third pass Finally the detailed information is reviewed for completeness and correctness fourth pass
Activity Monitors Physical activity will be monitored using an Actical accelerometer Mini Mitter Co Inc Bend Oregon The Actical activity monitoring device utilizes a multidirectional accelerometer to monitor the occurrence and intensity of motion The Actical device measures 3 cm by 3 cm weighs 170 grams and is securely attached to a waistband and placed around the waist The device can be worn and collect data for 42 days Data are uploaded and downloaded using an ActiReader Data include Daily Active Energy Expenditure and Total Daily Energy Expenditure Acticals activity count data is converted into minute-by-minute energy expenditure This is used to calculate daily caloric expenditure Physical activity will be monitored for a seven day period at baseline and at the 6 month time point post randomization
Plasma Cinnamon Metabolite Identification Plasma metabolites that constitute the active metabolite form of cinnamon will be tested while on steady state therapy at the 3 month time point Subjects will be instructed to take their morning dose of the study drug 2 hours - 30 minutes before their scheduled study visit They will be admitted to the clinical trial unit in the morning if possible Blood will be drawn for safety analysis as above as well as for active plasma metabolites Lunch will be provided A second blood draw for active metabolites will be obtained at 6 hours - 30 minutes after the first blood draw and just prior to the next cinnamon dose to test the difference in metabolites from 8 am to 2pm All blood samples for active metabolites will be batched and tested at the end of the trial to maintain blinding of the study Metabolites found to be significantly different p005 between experimental groups will be identified by searching our in-house library which contains 600 metabolites Mass Spectrometry Metabolite Library of Standards IROA Technologies LLC and 100 phytochemicals or our LipidView database which contains 25000 lipids When metabolites of interest are absent from our in-house library of metabolites and the LipidView database we will perform online database searches METLIN httpmetlinscrippsedu HMDB httpwwwhmdbca and MassBank httpwwwmassbankjplangen using their accurate masses When available database MSMS spectra will be used to further confirm the identity of the metabolite If a metabolite of interest is absent from all databases PeakView software AB SCIEX will be used to create a potential list of molecular formulas matching the measured mz value within 15 ppm error fragmentation pattern and isotopic distribution within 20 error For many of the metabolites identified synthetic standards can be purchased to confirm method specific MSMS spectra retention time experimental mz value and isotopic distribution
This Phase 2 study will be done prospectively and will be conducted in two stages The initial stage will be the general study and the second stage will be the sub-study We plan to screen up to 1000 subjects Our enrollment goal is 250 subjects total with 50 subjects enrolled in the sub-study and 200 subjects enrolled in the general study
Adults will be screened from Oregon Health Science University clinics cardiology internal medicine endocrinology obstetrics and gynecology family practice through Epic-based database searches and research flyer distribution At OHSU the Research Data Warehouse RDW will be used to identify potential subjects and recruitment letters will be sent out Additional advertisement will be conducted through March Wellness and the medical exercise program Further outreach advertising will be done through the Oregon Association of Naturopathic Physicians OANP website and the Naturopathic Doctor News Reviews NDNR newsletter
We will not include any vulnerable populations We will not recruit prisoners children neonates andor adults lacking capacity
In the event of a screen failure the data collected in screening will be retained to avoid future re-contacting for recruitment for this study The data will be handled in a confidential manner until destroyed at the end of enrollment
InclusionExclusion Criteria
Recruited subjects will meet the following criteria
Inclusion Criteria
Males and females ages 30-65 years of age
Diagnosed Type 2 diabetes with a HbA1c of 65-9 treated with either lifestyle alone or with metformin
Weight stable for 3 months as defined by no greater than a 5 change
Exclusion Criteria
Pregnancy
Breast feeding
Use of any other diabetes treatment other than metformin within the past 3 months
Type 1 diabetes
HbA1c 9 or less than 65
Liver disease with a known diagnosis of cirrhosis
Liver Dysfunction with AST or ALT liver enzymes 2x upper limit of normal
Chronic Kidney Disease with glomerular filtration rate 45 mlmin173m2
Anemia with hematocrit 30
TSH 5 or 04 mIUL
Coagulopathy INR 13
Use of warfarin or other new oral anticoagulants dabigatran rivaroxaban apixaban
Use of subcutaneous heparin enoxaparin dalteparin
Use of class 1 or class 3 anti-arrhythmic medications disopyramide procainamide quinidine mexilitine flecanide propafenone amiodarone sotalol dronedarone dofetilide
Use of immunosuppressants methotrexate prednisone tacrolimus sirolimus azathioprine mycophenolate cyclosporine
Chronic use of benzodiazepines midazolam alprazolam lorezepam temezepam diazepam clonazepam chlordiazepoxide for the past 3 months
Chronic use of medications that may affect body weight glucose or lipid metabolism eg anti-psychotics anti-seizure weight loss meds for the past 3 months
Patients with celiac sprue or gluten sensitive individuals
Self-report of 3 alcoholic drinks per day
Congestive heart failure ejection fraction 45
Known hypersensitivity to Definity ultrasound contrast agent for sub-study
Intra-cardiac or pulmonary shunt
Screening Visit
After receiving a verbal and graphical summary of the study subjects may opt into the General Study or a more detailed Mechanistic Sub-Study See below
Baseline Visit and Week 6 to 24 Study Visits in the General Study
Once subjects are screened those that have consented and are enrolled in the General Study will undergo the following tests and procedures
1 For women of child bearing potential a urine pregnancy test will be performed This must be done prior to iDEXA scan and should be done prior to randomization
2 Complete chemistry panel for liver and kidney function fasting insulin complete blood count CBC fasting lipid panel urine analysis and iDEXA scan for body composition Subject must be fasting for 8 hours Any remaining blood samples after being used for this study will be stored in the repository
3 Subjects will have an Actical monitor fit to their waist to wear for one week
4 24 hour food recalls will be performed by study staff The recalls will be conducted over the phone three separate times within 14-21 days at baseline and at 24 weeks
5 Prior to baseline visit discharge subjects will be randomized in a double blinded fashion in a 11 ratio to either 750 mg of cinnamon cassia or placebo three times daily for 24 weeks
6 Pills will be picked up and empty bottles returned for pill count by study staff at every visit
7 After 6 weeks of treatment subjects will have blood and urine testing for safety monitoring liver function tests CBC and urine analysis
8 After 12 weeks of treatment an HbA1c fasting insulin and fasting lipid panel will be drawn for an interim analysis Repeat safety profile with a complete chemistry panel for liver and kidney function and CBC will also be obtained Subject must be fasting for 8 hours
9 After 24 weeks of therapy subjects will return for a final visit in which all baseline tests and procedures will be repeated blood draw urine test iDEXA Actical food recalls
10 Adverse events and concomitant medications will be reviewed
11 Baseline visit will occur 10 5 days from the screening visit
12 All follow-up visits Weeks 6-24 will be done 7 days
Baseline Visit and Week 6 to 24 Study Visits in the Sub-Study
Those subjects that have consented and are enrolled in the Mechanistic Sub-Study will undergo the following baseline tests and procedures
On Day 1 of baseline testing the following tests will be performed
1 For women of child bearing potential a urine pregnancy test will be performed This must be done prior to iDEXA scan and should be done prior to randomization
2 Complete chemistry panel for liver and kidney function fasting insulin CBC fasting lipid panel HbA1c urine analysis and iDEXA scan for body composition Any remaining blood samples after being used for this study will be stored in the repository
On Day 2 of baseline testing within 1 week of Day 1 the following tests will be performed
1 Oral glucose tolerance test with a plasma sample obtained just prior to and after glucose ingestion for GI secretory function analysis
2 Subjects will have an Actical activity monitor fit to their waist to wear for a week
3 24 hour food recalls will be scheduled and performed by study staff
Following completion of these baseline studies subjects will be randomized in a double blinded fashion in a 11 ratio to either 750 mg of cinnamon cassia or placebo three times daily for 24 weeks
At the 6 and 18 week visit the following tests will be performed blood draw will be for safety with LFTs CBC and Urinalysis
At the 12 week visit the following tests and procedures will be performed
1 Subjects will be admitted to the CTRC for active metabolite testing
2 Subjects will have blood testing for safety monitoring complete chemistry panel with LFTs CBC and urinalysis and an HbA1c fasting insulin and fasting lipid panel drawn for an interim analysis
After 24 weeks of therapy subjects will return for a final visit in which all baseline tests will be repeated
Methods
All Methods below are research related inquiries
Dual X-Ray Absorptiometry DEXA Body composition total lean and fat mass and skeletal mineral content and body fat distribution will be measured by a trained technician in OHSUs Body Energy and Composition Core using a GE Healthcare Lunar iDEXA with encore software Pregnancy testing will be performed in all women prior to each total body scan If the results are positive the participant will be withdrawn from the study and referred to her personal health care provider
OGTT Following an overnight fast subjects will have an IV placed in an antecubital fossa After at least 15 minutes of rest three baseline samples will be obtained and the subject will then ingest 75 gm of glucose Blood for glucose insulin C-peptide glucagon GLP-1 and GIP will be obtained at times -15 -10 -5 015 30 60 90 120 and 180 minutes Proinsulin will be measured in one of the baseline samples Insulin sensitivity will be estimated using the Insulin Sensitivity Index 10000square root of fasting glucose x fasting insulin x mean glucose x mean insulin during OGTT 22 Insulin secretion capacity will be estimated using the Insulinogenic Index insulinogenic index delta area under the curve AUC insulin delta AUC glucose 23
Plasma Chemistries Total lipids total VLDL LDL and HDL cholesterol triglycerides and apolipoprotein B will be measured by the OHSU Lipid Lab Complete chemistry panel urine analysis HbA1C TSH and CBC will be performed through the OHSU Core Laboratory Insulin glucose C-peptide glucagon GLP-1 GIP ghrelin PYY pro-insulin apo B and adiponectin will be measured in the OCTRI Core Laboratory
24-Hour Diet Recall A series of three 24-hour food recall interviews will be done by telephone by trained OCTRI Bionutrition Unit staff to determine nutrient intake The recalls will be conducted over the phone three separate times within 14-21 days at baseline and at 6 months The series of three calls will occur once before the beginning of the intervention phase and again during the last week of Intervention 6 months to ensure to the extent possible that diet habits have been maintained The recalls will be unannounced and unscheduled so that participants are unlikely to change their normal eating habits All interviewers will have completed a training program and met qualification standards established in the OCTRI Bionutrition Unit and based on Nutrition Data System for Research NDSR NDSR is a computer based software application developed at the University of Minnesota Nutrition Coordinating Center NCC that facilitates the collection of recalls in a standardized fashion 19 Dietary intake data gathered by interview is governed by a multiple-pass interview approach 20 Four distinct passes provide multiple opportunities for the participant to recall food intake The first pass involves obtaining from the participant a listing of all foods and beverages consumed in the previous 24 hours This listing is reviewed with the participant for completeness and correctness second pass The interviewer then collects detailed information about each reported food and beverage including the amount consumed and method of preparation third pass Finally the detailed information is reviewed for completeness and correctness fourth pass
Activity Monitors Physical activity will be monitored using an Actical accelerometer Mini Mitter Co Inc Bend Oregon The Actical activity monitoring device utilizes a multidirectional accelerometer to monitor the occurrence and intensity of motion The Actical device measures 3 cm by 3 cm weighs 170 grams and is securely attached to a waistband and placed around the waist The device can be worn and collect data for 42 days Data are uploaded and downloaded using an ActiReader Data include Daily Active Energy Expenditure and Total Daily Energy Expenditure Acticals activity count data is converted into minute-by-minute energy expenditure This is used to calculate daily caloric expenditure Physical activity will be monitored for a seven day period at baseline and at the 6 month time point post randomization
Plasma Cinnamon Metabolite Identification Plasma metabolites that constitute the active metabolite form of cinnamon will be tested while on steady state therapy at the 3 month time point Subjects will be instructed to take their morning dose of the study drug 2 hours - 30 minutes before their scheduled study visit They will be admitted to the clinical trial unit in the morning if possible Blood will be drawn for safety analysis as above as well as for active plasma metabolites Lunch will be provided A second blood draw for active metabolites will be obtained at 6 hours - 30 minutes after the first blood draw and just prior to the next cinnamon dose to test the difference in metabolites from 8 am to 2pm All blood samples for active metabolites will be batched and tested at the end of the trial to maintain blinding of the study Metabolites found to be significantly different p005 between experimental groups will be identified by searching our in-house library which contains 600 metabolites Mass Spectrometry Metabolite Library of Standards IROA Technologies LLC and 100 phytochemicals or our LipidView database which contains 25000 lipids When metabolites of interest are absent from our in-house library of metabolites and the LipidView database we will perform online database searches METLIN httpmetlinscrippsedu HMDB httpwwwhmdbca and MassBank httpwwwmassbankjplangen using their accurate masses When available database MSMS spectra will be used to further confirm the identity of the metabolite If a metabolite of interest is absent from all databases PeakView software AB SCIEX will be used to create a potential list of molecular formulas matching the measured mz value within 15 ppm error fragmentation pattern and isotopic distribution within 20 error For many of the metabolites identified synthetic standards can be purchased to confirm method specific MSMS spectra retention time experimental mz value and isotopic distribution
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None