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

This study has been completed.
Sponsor:
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00876213
First received: April 3, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  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

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

Resource links provided by NLM:

Drug Information available for: Glucagon
U.S. FDA Resources

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, LLC.
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
ClinicalTrials.gov Identifier: NCT00876213     History of Changes
Other Study ID Numbers: KA-20060095
Study First Received: April 3, 2009
Last Updated: April 3, 2009
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

Additional relevant MeSH terms:
Glucagon-Like Peptide 1
Glucagon
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013