GIP Effects at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes (GIP-HYPO-T2DM)

March 31, 2013 updated by: Mikkel Christensen

Effects of Glucose-dependent Insulinotropic Polypeptide at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes

Investigation of GIP effects at fasting and hypoglycemia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Early 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
      • 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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Caucasians 18 years or older with Type 2 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 og IV)
  • Anemia
  • treatment with medication not applicable to pause for 12 hours
  • Fasting plasma glucose >15 mM on screening day.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hyperglycemia
Other: saline
Other: Glucose-dependent Insulinotropic polypeptide
infusion 4 pmol x kg x min first 15 min, thereafter 2 pmol x kg x min
Experimental: fasting glycemia
Other: saline
Other: Glucose-dependent Insulinotropic polypeptide
infusion 4 pmol x kg x min first 15 min, thereafter 2 pmol x kg x min
Experimental: hypoglycemia
Other: saline
Other: Glucose-dependent Insulinotropic polypeptide
infusion 4 pmol x kg x min first 15 min, thereafter 2 pmol x kg x min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
glucagon/insulin(c-peptide) 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

Secondary Outcome Measures

Outcome Measure
Time Frame
plasma gut hormones and nutrients
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

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

May 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

August 5, 2011

First Submitted That Met QC Criteria

August 10, 2011

First Posted (Estimate)

August 11, 2011

Study Record Updates

Last Update Posted (Estimate)

April 2, 2013

Last Update Submitted That Met QC Criteria

March 31, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2-2009-078

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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