Healthy, Type 2 Diabetes
Conditions
Keywords
GLP-1, Insulin secretion, Macronutrients
Brief summary
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).
Detailed description
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).
Interventions
DRUGSitagliptin
100 mg sitagliptin before ingestion of macronutrient
DRUGplacebo
A placebo tablet is given before ingestion of macronutrients
Sponsors
Lund University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy men * Age 20-30 years * BMI 20-30 kg/m2
Exclusion criteria
* Any disease * Any medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucagon-like Peptide-1 Secretion After Meal Ingestion | 300 min | Plasma GLP-1 levels will be measured during 300 min after meal ingestion for estimation of GLP-1 secretion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Secretion After Ingestion of Meal | 300 min | Plasma insulin levels will be measured during 300 min after meal ingestion to estimation of insulin secretion |
Countries
Sweden
Participant flow
Recruitment details
Recruitment was performed during 2011 to Lund University
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Placebo first, then sitagliptin or sitagliptin first, then placebo | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 22.5 years STANDARD_DEVIATION 1.9 |
| Region of Enrollment Sweden | 12 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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
Time frame: 300 min
Population: Completer population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Glucagon-like Peptide-1 Secretion After Meal Ingestion | 0.82 nmol/l/min | Standard Error 0.11 |
| Sitagliptin | Glucagon-like Peptide-1 Secretion After Meal Ingestion | 1.24 nmol/l/min | Standard Error 0.13 |
Secondary
Insulin Secretion After Ingestion of Meal
Plasma insulin levels will be measured during 300 min after meal ingestion to estimation of insulin secretion
Time frame: 300 min
Population: Completer population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Insulin Secretion After Ingestion of Meal | 29.6 mol/l/min | Standard Error 2.8 |
| Sitagliptin | Insulin Secretion After Ingestion of Meal | 24.7 mol/l/min | Standard Error 2.2 |