Extra-pancreatic Incretin Effect Clinical Trial
Official title:
Determining the Extra-pancreatic Effects of Incretin Hormones During Euglycemic and Hyperglycemic Pancreatic Clamps
| Verified date | December 2014 |
| Source | Rigshospitalet, Denmark |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Denmark: Ethics Committee |
| Study type | Interventional |
Incretin hormones (GLP-1 and GIP) released from the intestine in response to meal ingestion augment insulin secretion from the pancreas to help maintain glycemic control. Studies in vitro and in vivo have shown that these incretin hormones also have functional effects in other tissues independent of the insulin secretory response. Both GLP-1 and GIP stimulate insulin secretion in a glucose-dependent manner, however the glucose-dependency of their extra-pancreatic effects has not been examined in vivo. By using pancreatic clamp methodology during euglycemic and hyperglycemic conditions we will test the hypothesis that extra-pancreatic effects of GLP-1 and GIP are glucose-dependent.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | March 2014 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - age 18-60 years - BMI 18-30 kg/m2 - Male - Normal glycemic control (fasting glucose <5.6 mM) Exclusion Criteria: - Evidence of chronic disease - Smoking - Active weight loss (>2 kg in previous 6 months) - Treatment with drugs known to affect our outcome varaibles |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Rigshospitalet | Copenhagen | Capital Region |
| Lead Sponsor | Collaborator |
|---|---|
| Rigshospitalet, Denmark |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Glucose metabolism | Pancreatic clamp will be performed including infusion of somatostatin and replacement of basal insulin, glucagon, and growth hormone. During pancreatic clamps, euglycemia (5 mM) will be maintained via exogenous glucose infusion for the first 2-hours, followed by hyperglycemia (+5 mM) for the final 2-hours. An infusion of the stable isotope [U13C]glucose will be performed to assess glucose kinetics. Expired air will be collected for the analysis of [U13C]glucose into 13CO2. | up to 4 hours | No |
| Primary | Lipid metabolism | An infusion of the stable isotope [D5]glycerol will be performed to assess glycerol kinetics. | up to 4 hours | No |
| Secondary | Endothelial function | Ultrasound Doppler will be used to examine lower and upper limb blood flow and flow-mediated dilation | Baseline, 2 hours, and 4 hours | No |
| Secondary | Signaling | Skeletal muscle (vastus lateralis) and subcutaneous abdominal adipose biopsies will be obtained under local anaesthetic by the Bergstrom needle technique. Intracellular signalling related to glucose and lipid metabolism will be measured. | Baseline, 2 hours, and 4 hours | No |