Incretins and Metabolism

NCT ID: NCT01607944

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Normal Glucose Tolerance

No interventions assigned to this group

Type 2 Diabetes

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Thomas Solomon

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas P Solomon, PhD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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NNF2012

Identifier Type: -

Identifier Source: org_study_id