Status:
COMPLETED
Amylin and Glucagon-Like Peptide-1 (GLP-1): Influence on Gastric Emptying, Appetite and Food Intake in Humans
Lead Sponsor:
Hvidovre University Hospital
Collaborating Sponsors:
Amylin Pharmaceuticals, LLC.
Conditions:
Diabetes
Eligibility:
MALE
18-50 years
Brief Summary
The aim of this proposal is to dissect the mechanisms controlling gastric emptying, appetite and food intake in humans, and to obtain new knowledge to fight obesity on a pharmacological basis.
Detailed Description
The objective of the present study is to elucidate the mechanisms behind the effects of glucagon-like peptide-1 (GLP-1) on gastric emptying, appetite and food intake. The first GLP-1 based anti-diabet...
Eligibility Criteria
Inclusion
- Patients with type 1 diabetes
- Informed oral and written consent
- Caucasians over the age of 18 years with type 1 diabetes (diagnosed according to the criteria of WHO) receiving long acting insulin
- C-peptide negative glucagon test
- Normal blood haemoglobin concentration
- Healthy control subjects
- Informed oral and written consent
- Caucasians over the age of 18 years
- Normal 75 g- oral glucose tolerance test (OGTT) according to the criteria of WHO
- Negative islet cell autoantibodies (ICA) and GAD-65 autoantibodies
- No first-degree relatives with diabetes
- Normal blood haemoglobin concentration
Exclusion
- Patients with type 1 diabetes
- Residual beta-cell function (evaluated with glucagon test)
- Impaired hepatic function (aspartate aminotransferase (ASAT) and/or alanine aminotransferase (ALAT) \> 2 times upper normal limit)
- Diabetic nephropathy (serum-creatinine \> 130 µM and/or albuminuria)
- Diabetic neuropathy
- Proliferative diabetic retinopathy
- Pregnancy, breastfeeding or intention of becoming pregnant or judged to be using inadequate contraceptive measures
- Healthy control subjects
- Impaired hepatic function (ASAT or ALAT \> 2 times upper normal limit)
- Impaired renal function (serum-creatinine \> 130 μM and/or albuminuria)
- First-degree relatives with diabetes
- Pregnancy, breastfeeding or intention of becoming pregnant or judged to be using inadequate contraceptive measures
Key Trial Info
Start Date :
March 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00876213
Start Date
March 1 2007
End Date
June 1 2008
Last Update
April 6 2009
Active Locations (1)
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1
Hvidovre Hospital
Hvidovre, Hvidovre, Denmark, 2650