Incretins and Metabolism

NCT01607944 | Completed

• 1 other identifier: NNF2012
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Blood flow and flow-mediated dilation

  0, 1, 2, 3, 4 hours

• Palmitate turnover and oxidation

  0, 1, 2, 3, 4 hours

Study Arms (2)

Normal Glucose Tolerance

Type 2 Diabetes

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Local community volunteers

You may qualify if:

• age 18-60 years
• BMI 18-35 kg/m2
• NGT or T2DM as classified by ADA criteria

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Thomas P Solomon, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 23, 2012
• First Posted: May 30, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

DK (1)