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Incretins and Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01607944
Recruitment Status : Completed
First Posted : May 30, 2012
Last Update Posted : December 3, 2014
Information provided by (Responsible Party):
Thomas Solomon, Rigshospitalet, Denmark

Brief 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.

Condition or disease
Type 2 Diabetes

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

Normal Glucose Tolerance
Type 2 Diabetes

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Blood flow and flow-mediated dilation [ Time Frame: 0, 1, 2, 3, 4 hours ]
  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Local community volunteers

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01607944

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Copenhagen, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
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Principal Investigator: Thomas P Solomon, PhD Rigshospitalet, Denmark
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Responsible Party: Thomas Solomon, Associate Professor, Rigshospitalet, Denmark Identifier: NCT01607944    
Other Study ID Numbers: NNF2012
First Posted: May 30, 2012    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014