Incretins and Metabolism
|ClinicalTrials.gov Identifier: NCT01607944|
Recruitment Status : Completed
First Posted : May 30, 2012
Last Update Posted : December 3, 2014
Incretin hormones (GLP-1 and GIP) have insulin secretory effects on the pancreas that are glucose dependent. Extrapancreatic effects of incretin hormones are reported, however the glucose dependency of these effects have not been examined. In type 2 diabetes, pancreatic endocrine function and incretin metabolism are impaired. The investigators hypothesize that extrapancreatic effects of incretin hormones are glucose depedent and dysregulated in subjects with type 2 diabetes.
Healthy control subjects and type 2 diabetics will undergo pancreatic clamps. In brief, somatostatin will be infused to inhibit pancreatic endocrine function and basal levels of insulin, glucagon, and growth hormone will be replace via infusion. Metabolic flux will be studied during euglycemic and hyperglycemic stages of the pancreatic clamp. Each subject will undergo 3 trials involving the co-infusion of either saline(Control Trial), GLP-1, or GIP. Glucose metabolism will be assessed using 13C-glucose stable isotope methodology combined with indirect calorimetry and expired breath isotope ratio analysis. Blood flow and flow-mediated dilation will be measured using ultrasound Doppler. Skeletal muscle and abdominal adipose biopsies will be taken to examine intracellular signalling.
|Condition or disease|
|Type 2 Diabetes|
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Observational Model:||Case Control|
|Official Title:||The Extrapancreatic Metabolic Effects of Incretin Hormones|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||December 2014|
|Normal Glucose Tolerance|
|Type 2 Diabetes|
- Glucose turnover [ Time Frame: 0, 1, 2, 3, 4 hours ]Rates of appearance and disappearance (g/min) will be measured by examining [6,6-2H2]glucose enrichment in plasma.
- Blood flow and flow-mediated dilation [ Time Frame: 0, 1, 2, 3, 4 hours ]
- Palmitate turnover and oxidation [ Time Frame: 0, 1, 2, 3, 4 hours ]Rates of appearance and disappearance (g/min) will be measured by examining [U13C]palmitate enrichment in plasma. Rate of oxidation (g/min) will also be measured by examining 13C incorporation into CO2 in expired breath.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607944
|Principal Investigator:||Thomas P Solomon, PhD||Rigshospitalet, Denmark|