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Regulation of endogenous glucose production (EGP) and insulin secretion are major actions of glucagon-like peptide-1 (GLP-1). Determining whether alterations in GLP-1 may contribute to abnormal EGP and insulin secretion in people with impaired fasting glucose (IFG) was the objective of the current study. The investigators hypothesized that defects in GLP-1 may explain the inappropriate basal EGP and diminished insulin secretion in IFG, and, furthermore, that by increasing circulating GLP-1 levels (using a new medicine called "sitagliptin") the investigators could reverse these defects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Impaired Fasting Glucose | Experimental | Treatment of people with impaired fasting glucose with Januvia (sitagliptin phosphate) |
|
| Normal glucose tolerance | Experimental | Treatment of people with normal glucose tolerance with Januvia (sitagliptin phosphate) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin Phosphate | Drug | Januvia 100 mg po qd x 28 days for all subjects after baseline measures made |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Endogenous Glucose Production | Baseline and 28 days | |
| Change in Insulin Secretion | Baseline and 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Secretion in Response to Oral vs. IV Glucose | Baseline | |
| Baseline and Change in Hormones, Substrates and Insulin Action: C-peptide | Baseline and 28 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leigh Perreault, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20708814 | Derived | Perreault L, Man CD, Hunerdosse DM, Cobelli C, Bergman BC. Incretin action maintains insulin secretion, but not hepatic insulin action, in people with impaired fasting glucose. Diabetes Res Clin Pract. 2010 Oct;90(1):87-94. doi: 10.1016/j.diabres.2010.06.012. Epub 2010 Aug 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | People With Impaired Fasting Glucose | people with impaired fasting glucose Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made |
| FG001 | People With Normal Glucose Tolerance | people with normal glucose tolerance Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | People With Impaired Fasting Glucose | people with impaired fasting glucose Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made |
| BG001 | People With Normal Glucose Tolerance |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Endogenous Glucose Production | Posted | Mean | Standard Deviation | mg/kg/min | Baseline and 28 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | People With Impaired Fasting Glucose | people with impaired fasting glucose Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leigh Perreault, MD | University of Colorado Anschutz Medical Campus | 303-249-7732 | leigh.perreault@ucdenver.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Baseline and Change in Hormones, Substrates and Insulin Action: Glucagon |
| Baseline and 28 days |
| Baseline and Change in Hormones, Substrates and Insulin Action: GLP-1 | Baseline and 28 days |
| Baseline and Change in Hormones, Substrates and Insulin Action: Lactate | Baseline and 28 days |
| Baseline and Change in Hormones, Substrates and Insulin Action: FFA | Baseline and 28 days |
| Baseline and Change in Hormones, Substrates and Insulin Action: Glycerol | Baseline and 28 days |
people with normal glucose tolerance
Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Change in Insulin Secretion | Posted | Mean | Standard Deviation | pmol/l | Baseline and 28 days |
|
|
|
| Secondary | Insulin Secretion in Response to Oral vs. IV Glucose | Despite significant efforts to recover the data, data for this outcome measure could not be obtained and is not available. | Posted | Baseline |
|
|
| Secondary | Baseline and Change in Hormones, Substrates and Insulin Action: C-peptide | Posted | Mean | Standard Deviation | nmol/l | Baseline and 28 days |
|
|
|
| Secondary | Baseline and Change in Hormones, Substrates and Insulin Action: Glucagon | Posted | Mean | Standard Deviation | ng/l | Baseline and 28 days |
|
|
|
| Secondary | Baseline and Change in Hormones, Substrates and Insulin Action: GLP-1 | Posted | Mean | Standard Deviation | pmol/l | Baseline and 28 days |
|
|
|
| Secondary | Baseline and Change in Hormones, Substrates and Insulin Action: Lactate | Posted | Mean | Standard Deviation | mmol/l | Baseline and 28 days |
|
|
|
| Secondary | Baseline and Change in Hormones, Substrates and Insulin Action: FFA | Posted | Mean | Standard Deviation | umol/l | Baseline and 28 days |
|
|
|
| Secondary | Baseline and Change in Hormones, Substrates and Insulin Action: Glycerol | Posted | Mean | Standard Deviation | umol/l | Baseline and 28 days |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | People With Normal Glucose Tolerance | people with normal glucose tolerance Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made | 0 | 15 | 0 | 15 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D011719 |
| Pyrazines |