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OpenTrials
Completed

NCT Number: NCT00767208

Diabetes and Metabolic Postprandial Responses

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.

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Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Recherche En Nutrition Humaine Rhone Alpes

Lyon, 69000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral glucose load

Other

oral ingestion of 13C labeled glucose

Primary outcomes

  1. Apparition of exogenous glucose in plasma in the postprandial phase and its effect on carbohydrate and lipid metabolism

    Time frame: 6 hours postprandially

Secondary outcomes

  1. Postprandial concentrations of glucose, non esterified fatty acids, insulin and triglycerides

    Time frame: 6 hours postprandially

  2. Carbohydrate and lipid oxidation

    Time frame: 6 hours postprandially

Sponsors and collaborators

Lead sponsor

Centre de Recherche en Nutrition Humaine Rhone-Alpe

Other

Collaborators

  • LESAFFRE SA

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2008
First posted
Oct 7, 2008
Registry last updated
May 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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