GIP and GLP-1 in Type 1 Diabetes

July 10, 2015 updated by: Mikkel Christensen
Investigation of Glucose-dependent Insulinotropic Polypeptide (GIP) effects at hyper and hypoglycemia in type 1 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

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
      • Hellerup, Denmark, 2900
        • Gentofte 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

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

• Diagnosed with type 1 diabetes (WHO criteria)

Exclusion Criteria:

  • HbA1c > 9 %
  • Liver disease (ALAT/ASAT > 2 x upper normal limit)
  • Diabetic nephropathy (s-creatinine > 130 µM or albuminuria)
  • Proliferative diabetic retinopathy (anamnestic)
  • Severe arteriosclerosis or heart failure (NYHA group III or IV)
  • Anemia
  • treatment with medication not applicable to pause for 12 hours
  • C-peptide increase after 50 g iv arginine

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: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hyperglycemia
Hyperglycemic clamping
Other: Saline
Other: GIP
Experimental: hypoglycemia
Hypoglycemic clamping
Other: Saline
Other: GIP
Other: GLP-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
plasma glucagon area under curve values
Time Frame: approx. 15 minutes intervals, time 0 to 120 min
approx. 15 minutes intervals, time 0 to 120 min

Secondary Outcome Measures

Outcome Measure
Time Frame
plasma gut hormones and nutrients (absolute, incremental and area under curve values)
Time Frame: approx. 15 minutes intervals, time 0 to 120 min
approx. 15 minutes intervals, time 0 to 120 min

Other Outcome Measures

Outcome Measure
Time Frame
Glucose and glycerol tracer kinetics
Time Frame: approx. 15 minutes intervals, time 0 to 120 min
approx. 15 minutes intervals, time 0 to 120 min
glucose (g/kg body weight) needed to be infuse to keep clamp
Time Frame: approx. 15 minutes intervals, time 0 to 120 min
approx. 15 minutes intervals, time 0 to 120 min

Collaborators and Investigators

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

Sponsor

Mikkel Christensen

Collaborators

University of Copenhagen

Investigators

  • Principal Investigator: Mikkel Christensen, MD, Copenhagen University hospital, Gentofte

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

July 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

November 17, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (Estimate)

December 3, 2012

Study Record Updates

Last Update Posted (Estimate)

July 13, 2015

Last Update Submitted That Met QC Criteria

July 10, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2-2009-078 33269

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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