Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433173
Status:
SUSPENDED
Last Update Posted:
2010-03-02
First Post:
2007-02-08
Brief Title:
Insulin Sensitivity in Men With the Metabolic Syndrome
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome
Status:
SUSPENDED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Primary investigator is taking a leave of absence
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The metabolic syndrome is a medical condition defined by high levels of cholesterol in the blood high blood pressure central obesity gain in fat around the region of the stomach and insulin resistance body responds less well to insulin This state of impaired insulin resistance can lead to type 2 diabetes mellitus which is one of the most common metabolic disorders in the US Numerous studies have shown an inverse relationship between insulin resistance and testosterone levels in men however causality has not been established This protocol investigates the role of testosterone in modulating insulin sensitivity in insulin resistant states such as the metabolic syndrome The hypothesis is that testosterone administration will improve insulin sensitivity
Detailed Description:
This protocol will address the impact of three months of testosterone T therapy on all components of the metabolic syndrome and the mechanism underlying changes in insulin sensitivity by analyzing changes in body composition and detailed studies of fat metabolism and skeletal muscle In addition this protocol will address the role of estradiol E2 in mediating the effect of testosterone on insulin sensitivity
Seventy-two subjects will be enrolled Study subjects will undergo a screening visit to assess eligibility after which a baseline metabolic assessment will be performed including a a fasting oral glucose tolerance test OGTT to measure normal glucose and insulin metabolism an intravenous glucose tolerance test IVGTT to measure insulin sensitivity MRI and DEXA scan to assess muscle and body fat distribution VO2 max test and resting metabolic rate and a muscle biopsy to look at how the muscle is affected by insulin and testosterone T
Subjects will then be randomized to one of three 12-week treatment arms 1 Group 1 Placebo 2 Group 2 Depot GnRH agonist Zoladex Testosterone placebo or 3 Group 3 Zoladex Testosterone aromatase inhibitor anastrozole The rationale for this study design is as follows Under normal physiological conditions administration of T leads to a concomitant increase in estradiol E2 levels due to endogenous conversion by the aromatase enzyme system Therefore in order to understand the relative roles of T and E2 on insulin sensitivity one group of subjects will receive T in conjunction with the aromatase inhibitor anastrozole
At 13 weeks the entire baseline evaluation including OGTT IVGTT resting metabolic rate and VO2 max body composition assessment by DEXA and MRI and muscle biopsy will be repeated Subjects will return for a follow up visit four weeks later to measure CBC T and PSA levels to ensure levels are within the normal range
Seventy-two subjects will be enrolled Study subjects will undergo a screening visit to assess eligibility after which a baseline metabolic assessment will be performed including a a fasting oral glucose tolerance test OGTT to measure normal glucose and insulin metabolism an intravenous glucose tolerance test IVGTT to measure insulin sensitivity MRI and DEXA scan to assess muscle and body fat distribution VO2 max test and resting metabolic rate and a muscle biopsy to look at how the muscle is affected by insulin and testosterone T
Subjects will then be randomized to one of three 12-week treatment arms 1 Group 1 Placebo 2 Group 2 Depot GnRH agonist Zoladex Testosterone placebo or 3 Group 3 Zoladex Testosterone aromatase inhibitor anastrozole The rationale for this study design is as follows Under normal physiological conditions administration of T leads to a concomitant increase in estradiol E2 levels due to endogenous conversion by the aromatase enzyme system Therefore in order to understand the relative roles of T and E2 on insulin sensitivity one group of subjects will receive T in conjunction with the aromatase inhibitor anastrozole
At 13 weeks the entire baseline evaluation including OGTT IVGTT resting metabolic rate and VO2 max body composition assessment by DEXA and MRI and muscle biopsy will be repeated Subjects will return for a follow up visit four weeks later to measure CBC T and PSA levels to ensure levels are within the normal range
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 |
|---|---|---|---|
| NIDDK 1 RO1 DK071168-01A2 | None | None | None |