Diabetes and Metabolic Postprandial Responses
Comparison of Postprandial Metabolic Responses Between Type 2 Diabetic and Healthy Overweight Subjects
1 other identifier
interventional
24
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes
Started Jan 2005
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 6, 2008
CompletedFirst Posted
Study publicly available on registry
October 7, 2008
CompletedMay 20, 2009
May 1, 2009
1.3 years
October 6, 2008
May 19, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Apparition of exogenous glucose in plasma in the postprandial phase and its effect on carbohydrate and lipid metabolism
6 hours postprandially
Secondary Outcomes (2)
Postprandial concentrations of glucose, non esterified fatty acids, insulin and triglycerides
6 hours postprandially
Carbohydrate and lipid oxidation
6 hours postprandially
Study Arms (2)
type 2 diabetic subjects
EXPERIMENTALoverweight healthy subjects
EXPERIMENTALInterventions
oral ingestion of 13C labeled glucose
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre de Recherche en Nutrition Humaine Rhone-Alpelead
- LESAFFRE SAcollaborator
Study Sites (1)
Centre de Recherche En Nutrition Humaine Rhone Alpes
Lyon, 69000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 6, 2008
First Posted
October 7, 2008
Study Start
January 1, 2005
Primary Completion
May 1, 2006
Study Completion
May 1, 2008
Last Updated
May 20, 2009
Record last verified: 2009-05