Diabetes and Metabolic Postprandial Responses

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00767208
• Other study ID #: CRNHRA-06-002
• Status: Completed
• Phase: N/A
• First received: October 6, 2008
• Last updated: May 19, 2009
• Start date: January 2005
• Est. completion date: May 2008

Study information

• Verified date: May 2009
• Source: Centre de Recherche en Nutrition Humaine Rhone-Alpe
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2008
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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 Design

Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Overweight
• Type 2 Diabetes

Intervention

Other:
• oral glucose load
oral ingestion of 13C labeled glucose

Locations

Country	Name	City	State
France	Centre de Recherche En Nutrition Humaine Rhone Alpes	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Centre de Recherche en Nutrition Humaine Rhone-Alpe	LESAFFRE SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apparition of exogenous glucose in plasma in the postprandial phase and its effect on carbohydrate and lipid metabolism		6 hours postprandially	No
Secondary	Postprandial concentrations of glucose, non esterified fatty acids, insulin and triglycerides		6 hours postprandially	No
Secondary	Carbohydrate and lipid oxidation		6 hours postprandially	No