Quantification of the Incretin Effect in Healthy Subjects and Patients With Type 2 Diabetes

October 19, 2009 updated by: Herlev Hospital

Quantification of the Incretin Effect in Healthy Subjects and Patients With Type 2 Diabetes Using Increasing Amounts of Oral Glucose Challenges

Patients with T2DM lac a sufficient incretin response after oral glucose intake. It has only been tested using 50g of glucose. We don't know if patients with T2DM are capable of regulating the incretin effect like healthy people in responds to different amounts of glucose intake.

The aim of the present study is to quantify the incretin effect in healthy subjects and in patients with T2DM during increasing amounts of oral glucose challenges. The proposed studies will answer important questions on the mechanisms underlying T2DM and be of importance in relation to future preventive- and treatment strategies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The impaired incretin effect in patients with type 2 diabetes mellitus (T2DM) has previously only been evaluated using a glucose load of 50 g, and it is uncertain whether patients with T2DM are capable of regulating their incretin effect equivalent to healthy subjects. Furthermore, it is of great interest to quantify the secretion of GIP and GLP-1 during increasing glucose loads in both patients with T2DM and in healthy subjects in order to evaluate whether an increased secretion of one or both of the two incretin hormones contributes to the regulation of the incretin effect.

The aim of the present study is to quantify the incretin effect in healthy subjects and in patients with T2DM during increasing amounts of oral glucose challenges and corresponding isoglycemic iv glucose challenges. The proposed studies will answer important questions on the pathophysiology underlying T2DM and be of importance in relation to future preventive- and treatment strategies.

Eight patients with T2DM and 8 matched healthy subjects will be evaluated with oral glucose tolerance tests (OGTT) using increasing glucose loads (25, 50 and 100 g glucose) and isoglycemic iv glucose tolerance tests imitating the glucose concentrations as obtained during the oral glucose loads. The results will describe the regulation of the incretin effect in patients with T2DM and, thereby, contribute to the clarification of the pathophysiology of the postprandial hyperglycemia characterizing these patients.

Study Type

Observational

Enrollment (Actual)

16

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
    • Region Hovedstaden
      • Herlev, Region Hovedstaden, Denmark, 2730
        • Endokrinologisk afd. J, Herlev 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The Patients (Cases) will be recruted from the diabetes clinic at Depatment of Endocrinology at Herlev Hospital

The control subjects will be recruted through the lokal papers, and individualy matched by age, sex and BMI to a patient befor enrollment.

Description

Inclusion Criteria: Cases

  • Caucasians with T2DM according to WHO's criteria
  • Normal Hemoglobin
  • Agree to participate (orally and in writing)
  • HbA1c: 6.5-9 %
  • BMI: 23-35 kg/m2

Exclusion Criteria:Cases

  • Liver disease (ALAT > 2 x normal level)
  • Diabetic nephropathy (s-creatinin > 130 µM or albuminuria)
  • Diabetic neuropathy (anamnestic)
  • Proliferative diabetic retinopathy (anamnestic)
  • Medical treatment witch cannot be stopped for 12 hours
  • Pregnancy or breastfeed
  • Treatment with Insulin or glitazones

Inclusion Criteria: Control group

  • Caucasians
  • Normal oral glucose tolerance according to WHO's criteria
  • Normal Hemoglobin
  • Agree to participate (orally and in writing)
  • BMI: 23-35 kg/m2

Exclusion Criteria: Control group

  • Liver disease (ALAT > 2 x normal level)
  • Impaired function of the kidney (s-creatinin > 130 µM or albuminuria)
  • Directly related til to someone suffering from diabetes mellitus
  • Medical treatment witch cannot be stopped for 12 hours
  • Pregnancy or breastfeed

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
T2DM
T2DM patients (WHO-criteria)
Other: Oral Glucose Tolerance Test
The test is preformed 3 times with 3 different amounts of glucose (25g, 75g and 125g) deluded in 300ml of water.
Other: Isoglycemic clamp
I.v. glucose infusion initiating the glucose responds curves from the OGTT
Other: Gastric emptying rate
Paracetamol absorption test. Intake of 1,5g of paracetamol followed by measuring the absorption curve
CTRL
Healthy control subjects matched individually to the cases.
Other: Oral Glucose Tolerance Test
The test is preformed 3 times with 3 different amounts of glucose (25g, 75g and 125g) deluded in 300ml of water.
Other: Isoglycemic clamp
I.v. glucose infusion initiating the glucose responds curves from the OGTT
Other: Gastric emptying rate
Paracetamol absorption test. Intake of 1,5g of paracetamol followed by measuring the absorption curve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progress in Incretin effect in patients with T2DM compared with healthy subjects
Time Frame: 4 hours
4 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
GIP and GLP-1 responscurvs
Time Frame: 4 hours
4 hours

Collaborators and Investigators

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

Sponsor

Herlev Hospital

Collaborators

Merck Sharp & Dohme LLC
University of Copenhagen
Diabetesforeningen
Forskningsrådet

Investigators

  • Study Chair: Tina Villsbøll, MD.DMSc., Herlev Hospital
  • Study Director: Filip K Knop, MD.Phd., Herlev Hospital

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, 2007

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

September 12, 2007

First Submitted That Met QC Criteria

September 12, 2007

First Posted (Estimate)

September 14, 2007

Study Record Updates

Last Update Posted (Estimate)

October 20, 2009

Last Update Submitted That Met QC Criteria

October 19, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INK-GLUKOSE1

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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