Beta-Cell Function After Near-Normalisation of Blood Glucose

February 11, 2008 updated by: Hvidovre University Hospital

Four Weeks of Near Normalisation of Blood Glucose Improves the Insulin Response to GLP-1 and GIP in Patients With Type 2 Diabetes

The incretin effect is attenuated in patients with type 2 diabetes mellitus partly due to impaired potentiation of beta-cell responsiveness to glucose by glucose dependent insulinotropic polypeptide and glucagon-like peptide-1 respectively. The aim of the present study was to investigate whether 4 weeks of near-normalization of blood glucose could improve the insulin responses to GIP and GLP-1 in patients with type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

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
      • Copenhagen, Denmark
        • Dept. of Endocrinology, 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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-70 years
  • Type 2 diabetes diagnosed after 30 years of age
  • BMI > 25

Exclusion Criteria:

  • Severe complications to diabetes
  • Abnormal liver and kidney function
  • Haemoglobin below the lower limit
  • Macroalbuminuria
  • Systemic disease
  • Pregnancy

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: saline
Drug: Saline
continuous infusion of Saline for 120 min
Experimental: GLP-1
Drug: glucagon-like peptide-1,
GLP-1:continuous infusion of ½ pmol/kg/min for a total time of 120 minutes.
Experimental: GIP
Drug: glucose dependent insulinotropic polypeptide
continuous infusion of GIP (1½ pmol/kg/min) for 120 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
2.phase insulin response measured as incremental area under the curve from 10-120 minutes
Time Frame: 2 hours
2 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
2.phase insulin response measured as incremental area under the curve from 10-120 minutes, after 4 weeks of insulin treatment
Time Frame: 2 hours
2 hours

Collaborators and Investigators

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

Sponsor

Hvidovre University Hospital

Investigators

  • Principal Investigator: Patricia V Højberg, MD, PHD, University Hospital Hvidovre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2006

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

January 16, 2008

First Submitted That Met QC Criteria

February 11, 2008

First Posted (Estimate)

February 12, 2008

Study Record Updates

Last Update Posted (Estimate)

February 12, 2008

Last Update Submitted That Met QC Criteria

February 11, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA 03005

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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