Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Exenatide, a GLP-1 agonist approved for lowering blood glucose concentrations in patients with type 2 diabetes, has been associated with restoration of the first-phase insulin response when administered intravenously to patients with type 2 diabetes. In longer clinical trials, it is associated with progressive decreases in body weight, and improvement in the dyslipidemia that characterizes insulin resistance, although insulin resistance was not quantified. The investigators will seek to determine whether exenatide would have similar effects in individuals who were not diabetic. in particular, the drug effect on beta cell function and insulin sensitivity would be subject to less confounding by changes in blood glucose in the prediabetic population, allowing for clearer evaluation of the physiological effects of the drug on these metabolic endpoints. The investigators will compare 2 groups of prediabetic insulin resistant individuals, all on a weight loss diet and one group on exenatide and the other on placebo. The investigators will evaluate restoration of first phase insulin response, potential glucose lowering effects, including both reversal of prediabetes and hypoglycemia, and improvement in insulin resistance.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exenatide 5 and 10 mcg 2 times a day | Active Comparator | Exenatide in addition to weight loss. Starting dose 5 mcg titrate to 10 mcg |
|
| placebo | Placebo Comparator | placebo in addition to weight loss |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide 5 and 10 mcg 2 times a day | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| First-phase insulin response | measured using ivgtt | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| glucose lowering effect | measured by fasting and 2 hr plasma glucose during OGTT | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| insulin-mediated glucose uptake (insulin sensitivity) | This is measured by the SSPG, or modified insulin-suppression test. it is a "gold standard" measurement of insulin-mediated glucose uptake, and is precise and quantitative. | 8 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tracey McLaughlin, MS, MD | Stanford University | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D007333 | Insulin Resistance |
| D011236 | Prediabetic State |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo |
| Drug |
|
| D006946 | Hyperinsulinism |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |