Amylin and Glucagon-Like Peptide-1 (GLP-1): Influence on Gastric Emptying, Appetite and Food Intake in Humans - Full Text View

Sponsors and Collaborators:	Hvidovre University Hospital Amylin Pharmaceuticals, Inc.
Information provided by:	Hvidovre University Hospital
ClinicalTrials.gov Identifier:	NCT00876213

Purpose

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.

Condition
Diabetes

Drug Information available for: Glucagon-like peptide 1

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control
Official Title:	Amylin and GLP-1: Influence on Gastric Emptying, Appetite and Food Intake in Humans.

Further study details as provided by Hvidovre University Hospital:

Enrollment:	23
Study Start Date:	March 2007
Study Completion Date:	June 2008

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-diabetic therapy was approved by the FDA in 2005 and is now on the market in the United States. The strong glucose-dependent insulinotropic property of GLP-1 is a highly attractive feature in the pursue of optimal glycaemic control in type 2 diabetes.

Moreover, the potential of GLP-1 to reduce gastric emptying, appetite and food intake makes it an attractive tool in the fight against obesity, a pandemic condition that often leads to type 2 diabetes, and several companies are developing weight lowering drugs based on GLP-1. Interestingly, another peptide, amylin, exerts very similar effects on gastric emptying, appetite and food intake in humans. Amylin is found in insulin-rich granules in pancreatic beta-cells and is co-secreted with insulin upon insulinotropic stimuli. Currently, it is not known whether the inhibiting effects of GLP-1 on gastric emptying, appetite and food intake are directly mediated by GLP-1, or if the effects are secondary to the robust insulin responses, and thereby amylin responses, elicited by GLP-1. The objective of the present study is therefore to further elucidate the mechanisms of these effects in order to strengthen the development of anti-diabetic drugs with potential weight lowering capabilities.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Patients with type 1 diabetes and matched healthy control subjects

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876213

Locations

Denmark
Hvidovre Hospital
Hvidovre, Denmark, 2650

Sponsors and Collaborators

Hvidovre University Hospital

Amylin Pharmaceuticals, Inc.

Investigators

Principal Investigator:	Meena Asmar, MD,Ph.Dstud.	Panum Institut
Study Director:	Jens Juul Holst, Professor,MD	Panum Institut

More Information

No publications provided

Responsible Party:	University of Copenhagen ( University of Copenhagen )
Study ID Numbers:	KA-20060095
Study First Received:	April 3, 2009
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00876213 History of Changes
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Hvidovre University Hospital:

Amylin
GLP-1
gastric emptying
appetite and food intake

Study placed in the following topic categories:

Glucagon
Amylin
Diabetes Mellitus
Glucagon-Like Peptide 1

ClinicalTrials.gov processed this record on May 07, 2009