Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145093
Status:
COMPLETED
Last Update Posted:
2005-11-22
First Post:
2005-09-02
Brief Title:
Effects of Chromium Supplementation on Parameters of the Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus
Sponsor:
Medical Research Foundation The Netherlands
Organization:
Medical Research Foundation The Netherlands
Study Overview
Official Title:
The Effects of Organic Chromium Supplementation on Clinical Parameters of the Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus A Randomised Double-Blind Placebo-Controlled Trial
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether chromium yeast is effective in improving glycaemic control and insulin resistance
Detailed Description:
Setting
Patients meeting the inclusion and not the exclusion criteria will be sent a letter containing information about the study and that they will be called within 2 weeks by one of the investigators If the patient agrees to come for a fist visit he or she will be invited for a first visit to come to the general practice of Heerde
Informed Consent
During the telephone call and the first visit patients will be able to ask any question When the patient is properly informed and gives written informed consent the patient will be included for this study Specific items such as duration of the study the frequency of follow-up visits and the voluntary nature of participation will be discussed prior to obtaining informed consent Also because of potential reproductive toxicity no reports are known of developmental toxicity studies on Cr3 compounds given orally we will advice patients to take contraceptive precautions 33
Stop criteria
When a patient has any possible drug intolerance the patient will be asked to contact us We will note every possible side effect If there is any serious side effect the patient will be asked to stop with the intervention medication
Power and Sample Size Calculations
Sample size was calculated by using the computer program G-power Mean HbA1c of patients with HbA1c 7-85 in a general practise in our region is 770 SD 044 Powered to detect a 05 absolute reduction in HbA1c in the six-month follow-up of patients treated with chromium as compared to placebo patients With a power 95 alpha 005 2-tailed the total sample size is 44 22 in the first group and 22 in the second group
Randomisation
60 patients who will meet the inclusion criteria are randomly assigned in a double-blind trial to receive treatment A or B in addition to their current therapy for six months Method of blinding randomisation drug packages are labelled with the randomisation code by the hospital pharmacy Neither the physician nor the patient will be informed of the treatment There is no delay between study enrolment and randomisation
Intervention
Two treatment protocols are proposed Treatment A consist of 400 microgram Bio-chromiumday and treatment B consists of a placebo One type of chromium tablets will be made 100 microgram Crtablet Placebo is made to appear identical with the chromium tablets Patients are instructed to ingest 2 tablets of the study drug with breakfast and 2 with diner
Measures
Medical history consists of duration of diabetes diabetes medication general medication renal or hepatic diseases and recent complaints Body fat percentages will be measured using the OMRON BF306 HBF-306-E Patients are weighed while wearing clothes on bare feet Length is measured while standing on bare feet and blood pressure measured when the patient is in a sitting position according to the Dutch College of General Practitioners 34
Serum creatinine hepatic enzyme PT HbA1c Haemoglobin Hb fasting glucose fasting insulin serum total cholesterol LDL HDL and triglycerides will be measured at baseline with the standard procedure in our hospital Weezenlanden Location Isala Clinics
At baseline and after six months also serum chromium will be measured Extra citrate and serum collection tubes will be frozen for additional measurements when needed Also 24-h urine will be collected at baseline and after 6 months and volume creatinine protein and albumin will be measured Three tubes containing both 2 cc of urine will be frozen for additional measurements These extra analyses will only be made after given information and approval of the patient and after approval of the medical ethical committee
Follow up
At baseline an appointment will be made for the following visit and an appointment for a telephone call after 4 weeks During this call patients will be asked if they had any complaint which started after inclusion to this study For stimulating compliance patients will be asked how they use their tablets When this is different from described in this protocol patients will be advised accordingly Furthermore patients will be able to ask any question during this telephone call
Patients can call us when there is any possible adverse or toxic effects of the drug during office hours
After 3 months only HbA1c and Hb will be measured The other measures as described above except for length will be measured at baseline and after 6 months
Handling of losses to follow-up
Patients withdrawn from study medication will receive regular follow-up until the end of the 6-month follow-up period
Patients meeting the inclusion and not the exclusion criteria will be sent a letter containing information about the study and that they will be called within 2 weeks by one of the investigators If the patient agrees to come for a fist visit he or she will be invited for a first visit to come to the general practice of Heerde
Informed Consent
During the telephone call and the first visit patients will be able to ask any question When the patient is properly informed and gives written informed consent the patient will be included for this study Specific items such as duration of the study the frequency of follow-up visits and the voluntary nature of participation will be discussed prior to obtaining informed consent Also because of potential reproductive toxicity no reports are known of developmental toxicity studies on Cr3 compounds given orally we will advice patients to take contraceptive precautions 33
Stop criteria
When a patient has any possible drug intolerance the patient will be asked to contact us We will note every possible side effect If there is any serious side effect the patient will be asked to stop with the intervention medication
Power and Sample Size Calculations
Sample size was calculated by using the computer program G-power Mean HbA1c of patients with HbA1c 7-85 in a general practise in our region is 770 SD 044 Powered to detect a 05 absolute reduction in HbA1c in the six-month follow-up of patients treated with chromium as compared to placebo patients With a power 95 alpha 005 2-tailed the total sample size is 44 22 in the first group and 22 in the second group
Randomisation
60 patients who will meet the inclusion criteria are randomly assigned in a double-blind trial to receive treatment A or B in addition to their current therapy for six months Method of blinding randomisation drug packages are labelled with the randomisation code by the hospital pharmacy Neither the physician nor the patient will be informed of the treatment There is no delay between study enrolment and randomisation
Intervention
Two treatment protocols are proposed Treatment A consist of 400 microgram Bio-chromiumday and treatment B consists of a placebo One type of chromium tablets will be made 100 microgram Crtablet Placebo is made to appear identical with the chromium tablets Patients are instructed to ingest 2 tablets of the study drug with breakfast and 2 with diner
Measures
Medical history consists of duration of diabetes diabetes medication general medication renal or hepatic diseases and recent complaints Body fat percentages will be measured using the OMRON BF306 HBF-306-E Patients are weighed while wearing clothes on bare feet Length is measured while standing on bare feet and blood pressure measured when the patient is in a sitting position according to the Dutch College of General Practitioners 34
Serum creatinine hepatic enzyme PT HbA1c Haemoglobin Hb fasting glucose fasting insulin serum total cholesterol LDL HDL and triglycerides will be measured at baseline with the standard procedure in our hospital Weezenlanden Location Isala Clinics
At baseline and after six months also serum chromium will be measured Extra citrate and serum collection tubes will be frozen for additional measurements when needed Also 24-h urine will be collected at baseline and after 6 months and volume creatinine protein and albumin will be measured Three tubes containing both 2 cc of urine will be frozen for additional measurements These extra analyses will only be made after given information and approval of the patient and after approval of the medical ethical committee
Follow up
At baseline an appointment will be made for the following visit and an appointment for a telephone call after 4 weeks During this call patients will be asked if they had any complaint which started after inclusion to this study For stimulating compliance patients will be asked how they use their tablets When this is different from described in this protocol patients will be advised accordingly Furthermore patients will be able to ask any question during this telephone call
Patients can call us when there is any possible adverse or toxic effects of the drug during office hours
After 3 months only HbA1c and Hb will be measured The other measures as described above except for length will be measured at baseline and after 6 months
Handling of losses to follow-up
Patients withdrawn from study medication will receive regular follow-up until the end of the 6-month follow-up period
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