Is Insulin Resistance and/or Glucose Intolerance Pathogenetic in the Development of a Reduced Incretin Effect
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Incremental GLP-1 response during the mixed meal test. Assessed as AUC during the 4 hour test.
Study Overview
Brief Summary
The purpose of this study is to examine whether there is a causal relationship between insulin resistance and/or glucose intolerance in the development of a defect incretin effect.
Detailed Description
In this study we are going to examine the incretin effect before and after the development of insulin resistance and/or glucose intolerance. The incretin effect is the increased insulin response seen after an oral as apposed to an intravenous glucose challenge with identical plasma glucose profiles. This insulin enhancing effect is greatly reduced in type 2 diabetes.
Since the development of type 2 diabetes is preceded by insulin resistance and glucose intolerance we wanted to examine the incretin effect in the early stages of type 2 diabetes.
To do this, we want to induce insulin resistance and/or glucose intolerance. This is achieved by 5 days of treatment with dexamethasone.
The incretin effect in this study will be examined by 3 investigations prior to the treatment and 3 days following the treatment.
Day 1: Oral glucose challenge with 75 g of glucose.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Caucasians >20 years
- •Normal glucose tolerance as assessed by the WHO criteria
- •First degree relative and at least 1 second degree relative with type 2 diabetes
- •Normal haemoglobin
- •Informed consent
Exclusion Criteria
- •Liver disease (ALAT/ASAT > 2 times normal value)
- •Kidney disease (S-creatinin > 130uM and/or albuminuria)
- •Heart disease (NYHA II, III or IV)
- •Treatment with medicine that cannot be paused
- •Pregnancy of breast feeding
Arms & Interventions
Dexamethasone
Intervention: Dexamethasone (Drug)
Outcomes
Primary Outcomes
Incremental GLP-1 response during the mixed meal test. Assessed as AUC during the 4 hour test.
Time Frame: 4 hours (during the mixed meal test)
Secondary Outcomes
No secondary outcomes reported
Investigators
Kasper Aaboe
Doctor
University Hospital, Gentofte, Copenhagen