Glucose-dependent Insulinotropic Polypeptide - New Role as Blood Glucose Stabilizer?

July 10, 2015 updated by: Mikkel Christensen, University Hospital, Gentofte, Copenhagen
The purpose of this study is to determine whether glucose-dependent insulinotropic polypeptide (GIP) has a stabilizing function on the blood glucose

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of the study is to investigate the effect of GIP on the glucagon secretion during hyper-, eu- and hypoglycemia in healthy volunteers, patients with type 1 diabetes mellitus and patients with type 2 diabetes mellitus.

From this, we will evaluate GIP's role as blood sugar stabilizer.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 1

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 County
      • Hellerup, Copenhagen County, Denmark, 2900
        • Department of Internal Medicine F' laboratory

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Caucasians with T1DM (diagnosed according to WHO's criteria) without residual beta cell function (arginine test without increase in c-peptide) in treatment with long acting insulin OR
  • Caucasians with non-insulin treated T2DM (diagnosed according to WHO's criteria) OR
  • Caucasians without first degree relative with diabetes mellitus, with normal fasting plasma glucose and glucose tolerance along with negative islet and GAD-65 autoantibodies AND
  • Normal hemoglobin
  • Informed consent

Exclusion criteria:

  • Unwillingness to participate or the wish to leave the present study
  • HbA1c > 9 %
  • Liver disease (ALAT or ASAT > 2 times normal value)
  • Diabetic nephropathy (serum creatinin > 130 microM and/or albuminury)
  • Proliferative diabetic retinopathy (anamnetic)
  • Atherosclerotic heart disease or heart failure (NYHA group III and IV)
  • Anemia
  • Treatment with medicine which cannot be paused for 12 hours
  • Pregnancy and/or breast feeding
  • Fasting plasma glucose > 15 mM on the day of the experiment

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: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Healthy volunteers
Drug: glucose-dependent insulinotropic polypeptide

For the first 20 min of the experiment the volunteers will receive GIP at 4 pmol/kg body weight.

For the following 40 minutes the volunteers will receive 2 pmol/kg body weight

Drug: Placebo
copy GIP infusion rates
EXPERIMENTAL: Patients with Type 1 diabetes mellitus
Drug: glucose-dependent insulinotropic polypeptide

For the first 20 min of the experiment the volunteers will receive GIP at 4 pmol/kg body weight.

For the following 40 minutes the volunteers will receive 2 pmol/kg body weight

Drug: Placebo
copy GIP infusion rates
EXPERIMENTAL: Patients with type 2 diabetes mellitus
Drug: glucose-dependent insulinotropic polypeptide

For the first 20 min of the experiment the volunteers will receive GIP at 4 pmol/kg body weight.

For the following 40 minutes the volunteers will receive 2 pmol/kg body weight

Drug: Placebo
copy GIP infusion rates

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The difference in glucagon secretion quantified as the difference in plasma glucagon concentration and incremental baseline-subtracted area under the curve (AUC) for plasma glucagon
Time Frame: -10, 0, 5, 10, 20, 30, 45, 60 and 90 minutes at each visit
-10, 0, 5, 10, 20, 30, 45, 60 and 90 minutes at each visit

Secondary Outcome Measures

Outcome Measure
Time Frame
The difference between the amount of infused glucose and the insulin responses
Time Frame: will be measured at each visit
will be measured at each visit

Collaborators and Investigators

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

Sponsor

University Hospital, Gentofte, Copenhagen

Investigators

  • Principal Investigator: Mikkel Christensen, MD, Bispebjerg Hospital, Copenhagen
  • Study Director: Filip K Knop, MD PhD, Diabetes Research Division, Department of Internal Medicine F, Gentofte Hospital, University of Copenhagen

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

December 1, 2009

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

January 12, 2010

First Submitted That Met QC Criteria

January 12, 2010

First Posted (ESTIMATE)

January 13, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 14, 2015

Last Update Submitted That Met QC Criteria

July 10, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIP HYPO (MC)

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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