Diabetes and Metabolic Postprandial Responses | NCT00767208

Studies
Diabetes and Metabolic Postprandial Responses

NCT00767208

Sponsor

Centre de Recherche en Nutrition Humaine Rhone-Alpe

Status

Completed

Last Update Posted

May 20, 2009Estimated

Enrollment

Phase

Not Applicable

Conditions

Type 2 Diabetes
Overweight

Interventions

oral glucose load

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

May 2006Actual

Completion Date

May 2008Actual

First Submitted Date

Oct 6, 2008

First Submission Date that Met QC Criteria

Oct 6, 2008

First Posted Date

Oct 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2009

Last Update Posted Date

May 20, 2009Estimated

Name	Class
LESAFFRE SA	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
type 2 diabetic subjects	Experimental		Other: oral glucose load
overweight healthy subjects	Experimental		Other: oral glucose load

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oral glucose load	Other	oral ingestion of 13C labeled glucose	overweight healthy subjects type 2 diabetic subjects

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre de Recherche En Nutrition Humaine Rhone Alpes		Lyon		69000	France

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D050177	Overweight

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided