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

April 3, 2009 updated by: Hvidovre University Hospital

Amylin and GLP-1: Influence on Gastric Emptying, Appetite and Food Intake in Humans.

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Hvidovre Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with type 1 diabetes and matched healthy control subjects

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Collaborators

Amylin Pharmaceuticals, LLC.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

April 3, 2009

First Submitted That Met QC Criteria

April 3, 2009

First Posted (Estimate)

April 6, 2009

Study Record Updates

Last Update Posted (Estimate)

April 6, 2009

Last Update Submitted That Met QC Criteria

April 3, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KA-20060095

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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