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The regulation by DPP-4 inhibition after ingested of different individual macronutrients is not known. Therefore, this study examines the influence of ingestion of fat, protein, glucose or mixed meal on the concentrations of incretin hormones and insulin secretion with or without concomitant administration of a DPP-4 inhibitor (sitagliptin).
Meal ingestion releases gut hormones which stimulate insulin secretion. A most important gut hormone is the incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1 is rapidly degraded and inactivated after its release by the enzyme dipeptidyl peptidase-4 (DPP-4). Inhibition of DPP-4 therefore increases the concentration of active GLP-1 after meal ingestion, which augments insulin secretion. How this process is regulated after ingested of different individual macronutrients is not known. Therefore, this study examines the influence of ingestion of fat, protein, glucose or mixed meal on the concentrations of incretin hormones and insulin secretion with or without concomitant administration of a DPP-4 inhibitor (sitagliptin).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | A placebo tablet is given before ingestion of macronutrients |
|
| Sitagliptin | Active Comparator | Sitagliptin is given before ingestion of macronutrients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | 100 mg sitagliptin before ingestion of macronutrient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucagon-like Peptide-1 Secretion After Meal Ingestion | Plasma GLP-1 levels will be measured during 300 min after meal ingestion for estimation of GLP-1 secretion | 300 min |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Secretion After Ingestion of Meal | Plasma insulin levels will be measured during 300 min after meal ingestion to estimation of insulin secretion | 300 min |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bo Ahrén, MD, PhD | Lund University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Sciences Lund, Lund University | Lund | 221 84 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18612044 | Background | Carr RD, Larsen MO, Winzell MS, Jelic K, Lindgren O, Deacon CF, Ahren B. Incretin and islet hormonal responses to fat and protein ingestion in healthy men. Am J Physiol Endocrinol Metab. 2008 Oct;295(4):E779-84. doi: 10.1152/ajpendo.90233.2008. Epub 2008 Jul 8. | |
| 23331498 | Derived | Ohlsson L, Alsalim W, Carr RD, Tura A, Pacini G, Mari A, Ahren B. Glucose-lowering effect of the DPP-4 inhibitor sitagliptin after glucose and non-glucose macronutrient ingestion in non-diabetic subjects. Diabetes Obes Metab. 2013 Jun;15(6):531-7. doi: 10.1111/dom.12062. Epub 2013 Feb 7. |
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Recruitment was performed during 2011 to Lund University
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo First, Then Sitagliptin | First intervention 1 day, washout 14 days, second intervention 1 day |
| FG001 | Sitagliptin First, Then Placebo | First intervention 1 day, washout 14 days, second intervention 1 day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Placebo first, then sitagliptin or sitagliptin first, then placebo |
| 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 | Glucagon-like Peptide-1 Secretion After Meal Ingestion | Plasma GLP-1 levels will be measured during 300 min after meal ingestion for estimation of GLP-1 secretion | Completer population | Posted | Mean | Standard Error | nmol/l/min | 300 min |
|
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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 | All Study Participants | Placebo first, then sitagliptin or sitagliptin first, then placebo |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Bo Ahrén | Lund University | +46462220758 | Bo.Ahren@med.lu.se |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| 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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| placebo | Drug | A placebo tablet is given before ingestion of macronutrients |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Insulin Secretion After Ingestion of Meal | Plasma insulin levels will be measured during 300 min after meal ingestion to estimation of insulin secretion | Completer population | Posted | Mean | Standard Error | mol/l/min | 300 min |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
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| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |