Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00186459
Status:
UNKNOWN
Last Update Posted:
2013-03-13
First Post:
2005-09-13
Brief Title:
Obesity Weight Loss and Cardiovascular Disease Risk
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
GCRC-CAP-Tracey McLaughlin MD
Status:
UNKNOWN
Status Verified Date:
2013-03
Last Known Status:
ENROLLING_BY_INVITATION
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 goal of the study is to define the roles played by resistance to insulin-mediated glucose disposal insulin resistance and circulating plasma insulin concentrations in 1 ability to lose weight 2 reduction of risk for coronary heart disease as a result of weight loss We hypothesize that in the setting of caloric restriction manipulating endogenous insulin concentrations will not alter ability of subjects to lose weight but will lead to different reduction in CHD risk factors To test this hypothesis two parallel studs will be performed First obese insulin-resistant individuals will be randomized to one of two equally-hypocaloric diets that vary moderately in proportion of carbohydrate and monopolyunsaturated fats lower carbohydrate diet will be associated with greater reduction in endogenous insulin secretion Second diabetics treated with insulin secretagogues will be compared to diabetics treated with insulin sensitizers with respect to the same outcomes secretagogues increase insulin secretion and insulin sensitizers decrease insulin concentrations Endpoints include weight loss change in insulin resistance blood pressure lipid and lipoproteins markers of endothelial function daylong insulin and glucose concentrations these will be compared in each of the parallel studies between the group with insulin-stimulating intervention vs the group with the insulin-sparing intervention
Detailed Description:
While obesity insulin resistance and diabetes are highly associated it is not clear whether insulin resistance and compensatory hyperinsulinemia play important roles in the tendency to gain weight andor inability to lose weight The role of hyperinsulinemia in coronary heart disease CHDis also unclear The specific aims of the proposed research are as follows
1 To compare insulin resistant versus insulin sensitive nondiabetic overweight individuals with respect to their ability to lose weight on a low calorie diet CHD risk factors before and after weight loss will also be assessed to determine the degree to which insulin resistance is associated with CHD risk as well as the impact that differences in insulin resistance have on the metabolic benefits of weight loss
2 To determine if weight loss and its associated metabolic benefits vary as a function of the relative amounts of dietary fat and carbohydrate in hypocaloric diets Because high carbohydrate diets increase insulin secretion the relationship between dietary composition and change in circulating insulin concentrations will be analyzed with respect to both weight loss and CHD risk factors
3 To quantify and compare the improvement in glycemic control and CHD risk factors associated with weight loss in obese type 2 diabetics while being treated with 1 an insulin secretagogue sulfonylurea or 2 an insulin sensitizer thiazolidinedione Manipulation of plasma insulin concentrations with these medications will provide a mechanism by which to evaluate the impact of circulating insulin concentrations on the described outcome measures
4 A subgroup of overweightobese premenopausal women with PCOS will be studied using two diets in crossover design with regard to macronutrient effects on endogenous hyperinsulinism For this subgroup age range will be 18-50 years BMI 25-50 kgm2
5 In order to increase our data and therefore increase our better understanding of fat cells and insulin resistance and changes in fat cells with weight loss we would like to increase our participant enrollment to 550 all to be enrolled at Stanford University Medical Center recruiting Bariatric participants
Age for Bariatric patients 30-65 men and women BMI 27-no upper limit Currently we have completed all participants except the bariatric and post bariatric population and those with hypoglycemia following bariatric surgery
The ethnic background of subjects reflects Stanfords patient population
1 To compare insulin resistant versus insulin sensitive nondiabetic overweight individuals with respect to their ability to lose weight on a low calorie diet CHD risk factors before and after weight loss will also be assessed to determine the degree to which insulin resistance is associated with CHD risk as well as the impact that differences in insulin resistance have on the metabolic benefits of weight loss
2 To determine if weight loss and its associated metabolic benefits vary as a function of the relative amounts of dietary fat and carbohydrate in hypocaloric diets Because high carbohydrate diets increase insulin secretion the relationship between dietary composition and change in circulating insulin concentrations will be analyzed with respect to both weight loss and CHD risk factors
3 To quantify and compare the improvement in glycemic control and CHD risk factors associated with weight loss in obese type 2 diabetics while being treated with 1 an insulin secretagogue sulfonylurea or 2 an insulin sensitizer thiazolidinedione Manipulation of plasma insulin concentrations with these medications will provide a mechanism by which to evaluate the impact of circulating insulin concentrations on the described outcome measures
4 A subgroup of overweightobese premenopausal women with PCOS will be studied using two diets in crossover design with regard to macronutrient effects on endogenous hyperinsulinism For this subgroup age range will be 18-50 years BMI 25-50 kgm2
5 In order to increase our data and therefore increase our better understanding of fat cells and insulin resistance and changes in fat cells with weight loss we would like to increase our participant enrollment to 550 all to be enrolled at Stanford University Medical Center recruiting Bariatric participants
Age for Bariatric patients 30-65 men and women BMI 27-no upper limit Currently we have completed all participants except the bariatric and post bariatric population and those with hypoglycemia following bariatric surgery
The ethnic background of subjects reflects Stanfords patient population
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