Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361907
Status:
TERMINATED
Last Update Posted:
2016-08-09
First Post:
2006-04-13
Brief Title:
Effect of Pulsatile IV Insulin on Circulating Risk Markers of Vascular and Metabolic Complications in Pts With Diabetes
Sponsor:
Florida Atlantic University
Organization:
Florida Atlantic University
Study Overview
Official Title:
Effect of Pulsatile IV Insulin Delivery on Circulating Risk Markers of Vascular and Metabolic Complications in Pts With Diabetes
Status:
TERMINATED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administrative - Suspended by IRB
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 the effect of Pulsatile Intravenous Insulin therapy on circulating blood markers These blood markers are selected due to their correlation to and possible pathogenetic roles in vascular compromise and inflammatory malfunction in diabetic patients
Detailed Description:
Insulin produces vasodilatory anti inflammatory and anti thrombotic effects 1-4 However the effects of pulsatile intravenous insulin delivery on circulating risk factors for vascular and metabolic disease is unknown This study is used to evaluate circulating risk markers of vascular and metabolic disease compared to a matched control group
Protocol Patients selected have diabetes mellitus 20 years of age and older and are treated with oral agents andor insulin The study is for a minimum of 12 months and may continue for 2-3 years if a significant difference is shown following the initial 12 months Blood markers will be determined every 12 months for the first year and every 12 months after that They may include the following BNP fructosamine PAI-1 fibrinogen homocysteine endothelin 1 aldosterone VCAM ICAM IGF-1 TGF-beta TNF-alpha hs-CRP and IL-6 The results are compared to an age and fructosamine matched control group
Endpoints Changes in markers Statistics ANOVA Blood 2 purple 2 red 2 blue tops
The respiratory quotient RQ is a measurement of CO2 exhaled and O2 inhaled and is proportionate to the fuel sources being used by the body primarily the liver over short periods of time The higher the RQ the more glucose and less alternative fuel sources are being utilized Following the RQ change helps determine the effectiveness of physiological insulin administration in increasing anabolic functions in diabetic individuals By improving the bodys glucose metabolism and thereby causing beneficial effects of anabolic factors the possibility of serious complications can be decreased In addition the use of oral carbohydrate at the same time along with the physiologic insulin administration stimulates the appropriate gut hormones which augment this effect a response which cannot be duplicated with intravenous glucose The purpose of our studies is to determine whether the physiologic administration of pulsatile intravenous insulin along with the augmenting effect of oral carbohydrates will normalize metabolism in diabetic patients and improve their quality of life indices
The RQ is determined by the use of a metabolic cart Individuals breathe into a mask for 3-5 minutes after a rest period of 30 or more minutes The ratio of exhaled volume of CO2 to the inhaled volume of O2 is determined as the RQ The physiologic range is 07 to13 Individuals using fat as a primary fuel have a ratio of 07 protein or mixed fuels is 08-09 and carbohydrate is 09-10 Those taking excessive calories will have RQs higher than 105 The RQ can be followed serially and this is done twice before and after each treatment during the 3 successive sessions on a single treatment day The amount of intravenous insulin and oral glucose given is determined by the RQ changes during the previous session
Pusatile intravenous insulin delivery is a process which encourages the glucose metabolism in diabetics to normalize in multiple organs especially muscle retina liver kidney and nerve endings The process fundamentally requires the administration of high dose intravenous insulin pulses similar to those found in non diabetic humans by their pancreas into the surrounding portal circulation Oral carbohydrates are given simultaneously to augment the process and prevent hypoglycemia The process is monitored by frequent glucose level measurements and respiratory quotients RQ RQ is measured by a metabolic cart which determines the ratio VCO2 VO2 This ratio is specific for the fuel used at any one time by the body The glucose levels are monitored to keep glucose levels appropriate and the RQ determines the need to readjust the infusion protocol in each patient for subsequent insulin infusion sessions Pulsatile intravenous insulin delivery is done over 1-hour periods with a up to a 1-hour rest period between each session for three courses each day of activation
References
Katakam PVG Tulbert CD Snipes JA Erdos B Miller AW Busija DW Impaired Insulin-induced Vasodilation in Small Coronary Arteries of Zucker Obese rats is Mediated by Reactive Oxygen Species AJP-Heart 288854-60 2005
Chakraborty K Sinha AK The Role of Insulin as an Antithrombotic Humoral Factor BioEssays 2691-98 2003
Elias AN Eng S Homocysteine Concentrations in Patients with Diabetes Mellitus-Relationship to Microvascular and Macrovascular Disease Diabetes Obesity and Metabolism 7117-21 2005
Patiag D Qu X Gray S Idris I Wilkes M Seale JP Donnely R Possible Interactions between Angiotensin II and InsulinEffects on Glucose and Lipid Metabolism in vivi and in vitro Journal of Endocrinology 167 525-31 2000
Protocol Patients selected have diabetes mellitus 20 years of age and older and are treated with oral agents andor insulin The study is for a minimum of 12 months and may continue for 2-3 years if a significant difference is shown following the initial 12 months Blood markers will be determined every 12 months for the first year and every 12 months after that They may include the following BNP fructosamine PAI-1 fibrinogen homocysteine endothelin 1 aldosterone VCAM ICAM IGF-1 TGF-beta TNF-alpha hs-CRP and IL-6 The results are compared to an age and fructosamine matched control group
Endpoints Changes in markers Statistics ANOVA Blood 2 purple 2 red 2 blue tops
The respiratory quotient RQ is a measurement of CO2 exhaled and O2 inhaled and is proportionate to the fuel sources being used by the body primarily the liver over short periods of time The higher the RQ the more glucose and less alternative fuel sources are being utilized Following the RQ change helps determine the effectiveness of physiological insulin administration in increasing anabolic functions in diabetic individuals By improving the bodys glucose metabolism and thereby causing beneficial effects of anabolic factors the possibility of serious complications can be decreased In addition the use of oral carbohydrate at the same time along with the physiologic insulin administration stimulates the appropriate gut hormones which augment this effect a response which cannot be duplicated with intravenous glucose The purpose of our studies is to determine whether the physiologic administration of pulsatile intravenous insulin along with the augmenting effect of oral carbohydrates will normalize metabolism in diabetic patients and improve their quality of life indices
The RQ is determined by the use of a metabolic cart Individuals breathe into a mask for 3-5 minutes after a rest period of 30 or more minutes The ratio of exhaled volume of CO2 to the inhaled volume of O2 is determined as the RQ The physiologic range is 07 to13 Individuals using fat as a primary fuel have a ratio of 07 protein or mixed fuels is 08-09 and carbohydrate is 09-10 Those taking excessive calories will have RQs higher than 105 The RQ can be followed serially and this is done twice before and after each treatment during the 3 successive sessions on a single treatment day The amount of intravenous insulin and oral glucose given is determined by the RQ changes during the previous session
Pusatile intravenous insulin delivery is a process which encourages the glucose metabolism in diabetics to normalize in multiple organs especially muscle retina liver kidney and nerve endings The process fundamentally requires the administration of high dose intravenous insulin pulses similar to those found in non diabetic humans by their pancreas into the surrounding portal circulation Oral carbohydrates are given simultaneously to augment the process and prevent hypoglycemia The process is monitored by frequent glucose level measurements and respiratory quotients RQ RQ is measured by a metabolic cart which determines the ratio VCO2 VO2 This ratio is specific for the fuel used at any one time by the body The glucose levels are monitored to keep glucose levels appropriate and the RQ determines the need to readjust the infusion protocol in each patient for subsequent insulin infusion sessions Pulsatile intravenous insulin delivery is done over 1-hour periods with a up to a 1-hour rest period between each session for three courses each day of activation
References
Katakam PVG Tulbert CD Snipes JA Erdos B Miller AW Busija DW Impaired Insulin-induced Vasodilation in Small Coronary Arteries of Zucker Obese rats is Mediated by Reactive Oxygen Species AJP-Heart 288854-60 2005
Chakraborty K Sinha AK The Role of Insulin as an Antithrombotic Humoral Factor BioEssays 2691-98 2003
Elias AN Eng S Homocysteine Concentrations in Patients with Diabetes Mellitus-Relationship to Microvascular and Macrovascular Disease Diabetes Obesity and Metabolism 7117-21 2005
Patiag D Qu X Gray S Idris I Wilkes M Seale JP Donnely R Possible Interactions between Angiotensin II and InsulinEffects on Glucose and Lipid Metabolism in vivi and in vitro Journal of Endocrinology 167 525-31 2000
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MH42900 and MH01386 | OTHER | NIMH | None |