Incretins and Metabolism

Type 2 Diabetes Clinical Trial

Official title:

The Extrapancreatic Metabolic Effects of Incretin Hormones

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01607944
• Other study ID #: NNF2012
• Status: Completed
• Phase: N/A
• First received: May 23, 2012
• Last updated: December 2, 2014
• Start date: April 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• age 18-60 years

• BMI 18-35 kg/m2

• NGT or T2DM as classified by ADA criteria

Exclusion Criteria:

• Insulin dependency

• Smokers

• History of or presentation with cardiovascular disease, cancer, and chronic hematological, renal, hepatic, pulmonary disease

• Weight loss (>2 kg in previous 6 months)

• Physical activity (>150 mins/week)

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Type 2 Diabetes

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose turnover	Rates of appearance and disappearance (g/min) will be measured by examining [6,6-2H2]glucose enrichment in plasma.	0, 1, 2, 3, 4 hours	No
Secondary	Blood flow and flow-mediated dilation		0, 1, 2, 3, 4 hours	No
Secondary	Palmitate turnover and oxidation	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.	0, 1, 2, 3, 4 hours	No