Incretins and Metabolism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Solomon, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01607944
First received: May 23, 2012
Last updated: December 2, 2014
Last verified: December 2014
  Purpose

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
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Extrapancreatic Metabolic Effects of Incretin Hormones

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Glucose turnover [ Time Frame: 0, 1, 2, 3, 4 hours ] [ Designated as safety issue: No ]
    Rates of appearance and disappearance (g/min) will be measured by examining [6,6-2H2]glucose enrichment in plasma.


Secondary Outcome Measures:
  • Blood flow and flow-mediated dilation [ Time Frame: 0, 1, 2, 3, 4 hours ] [ Designated as safety issue: No ]
  • Palmitate turnover and oxidation [ Time Frame: 0, 1, 2, 3, 4 hours ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: April 2012
Study Completion Date: December 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal Glucose Tolerance
Type 2 Diabetes

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Local community volunteers

Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01607944

Locations
Denmark
Rigshospitalet
Copenhagen, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Thomas P Solomon, PhD Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Thomas Solomon, Associate Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01607944     History of Changes
Other Study ID Numbers: NNF2012
Study First Received: May 23, 2012
Last Updated: December 2, 2014
Health Authority: Denmark: Ethics Committee

ClinicalTrials.gov processed this record on March 26, 2015