Diabetes and Metabolic Postprandial Responses

May 19, 2009 updated by: Centre de Recherche en Nutrition Humaine Rhone-Alpe

Comparison of Postprandial Metabolic Responses Between Type 2 Diabetic and Healthy Overweight Subjects

The aim of this trial was to compare postprandial metabolic response to glucose load in healthy overweight and type 2 diabetic subjects, by using glycemia, insulinemia, lipid profile, nutrient oxidation follow-up. Stable isotopes of glucose were used to assess postprandial total,exogenous and endogenous glucose kinetics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

24

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

  • France
      • Lyon, France, 69000
        • Centre de Recherche en Nutrition Humaine Rhone Alpes

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

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Overweight or obese volunteers
  • Healthy for one group nd type 2 diabetic for the second group
  • Age between 30 and 65 years old
  • Total cholesterol < or = 7 mmol/l and triglycerides < or = 4 mmol/l
  • For diabetic group: treated by metformin and/or sulfonylurea and/or thiazolidinedione and HbA1c < 6%
  • Stable weight over last 3 months
  • Informed consent

Exclusion Criteria:

  • No compliant subjects
  • Participation in an other trial 2 months before starting this one
  • Ward of court or under guardianship (sheltered adults)
  • Person deprived of freedom by judicial or administrative decision
  • Type 1 diabetes and type 2 diabetes treated bu insulin or acarbose
  • Existence of a previously diagnosed pathology (other than type 2 diabetes)
  • Previous gastro-intestinal pathology
  • Treated by corticoids, anorexigens, weight loss medicines
  • Alcoholism or severe tobacco consumption

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

  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: type 2 diabetic subjects
Other: oral glucose load
oral ingestion of 13C labeled glucose
Experimental: overweight healthy subjects
Other: oral glucose load
oral ingestion of 13C labeled glucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Apparition of exogenous glucose in plasma in the postprandial phase and its effect on carbohydrate and lipid metabolism
Time Frame: 6 hours postprandially
6 hours postprandially

Secondary Outcome Measures

Outcome Measure
Time Frame
Postprandial concentrations of glucose, non esterified fatty acids, insulin and triglycerides
Time Frame: 6 hours postprandially
6 hours postprandially
Carbohydrate and lipid oxidation
Time Frame: 6 hours postprandially
6 hours postprandially

Collaborators and Investigators

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

Sponsor

Centre de Recherche en Nutrition Humaine Rhone-Alpe

Collaborators

LESAFFRE SA

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

January 1, 2005

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

October 6, 2008

First Submitted That Met QC Criteria

October 6, 2008

First Posted (Estimate)

October 7, 2008

Study Record Updates

Last Update Posted (Estimate)

May 20, 2009

Last Update Submitted That Met QC Criteria

May 19, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRNHRA-06-002

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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