Diabetes Prevention In Estrie

Overweight Clinical Trial

Official title:

Comparative Evaluation of the Effectiveness of 2 Available Resources in Estrie, for the Prevention of Type 2 Diabetes in High-risk Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00991549
• Other study ID #: 04-087
• Status: Completed
• Phase: N/A
• First received: October 7, 2009
• Last updated: October 7, 2009
• Start date: December 2004
• Est. completion date: January 2008

Study information

• Verified date: October 2009
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This study compared the efficacy at one year of an interdisciplinary approach including individual counseling and group seminars versus group seminars alone to induce weight loss in subjects at high risk of developing type 2 diabetes.

This study also compare if a participant's presence in small informative meeting groups as the only form of intervention is sufficient to induce a lifestyle change, thus inducing the weight loss needed for the prevention of the diseases associated with obesity.

Description:

Eligible participants will be randomized into 2 intervention groups (30 per group):

1. Small Meeting groups: a curriculum of 25 meeting-seminars will take place for 45 minutes, each one approaching various aspects of nutrition, physical activity, psychology, motivation and medical needs. These seminars are administered by the professionals of the obesity clinic and are already in place. However, these are usually only offered to the patients registered with the obesity clinic.

2. Obesity Clinic of CHUS: combination of 25 described meeting-seminars see-high, in addition to individual interviews every 6 weeks with the interdisciplinary team of the obesity clinic of CHUS (usual operation).

Subjects will be evaluated initially and then every 3 months during 1 year by the following measurements: questionnaires to evaluate motivation and physical activity; 3 day dietary journals; weight assessment, using both metabolic and mechanical balance; waist circumference; and blood pressure.

A medical evaluation with size measure, a test evaluating knowledge of the participants on obesity, OGTT (Oral Glucose Tolerance Test) - a 5 hour determination of secretion and resistance to insulin, insulin-mediated suppression of plasma non-esterified fatty acids, a plasma lipid profile, accelerometry, bio electric impedance, and an activity physical test (6 minute walk test) will be carried out initially, and then repeated for up to 1 year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: January 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• pre diabetic state underlined by a marginal fasting glycemia between 6,1 and 6,9 mmol/L and/or a glucose intolerance with glucose confirmed by an OGTT 2 hours

• overweight or obesity (BMI > 27 kg/m² ; (Body Mass Index))

• enlightened assent

Exclusion Criteria:

• Impossibility to be present at the visits

• Physical/motor incapacity (or other) making one unable and/or insecure to walk at a moderate to rapid speed of 6 min and more

• Use of an anti-obesity treatment during the last 3 months

• Bariatric Surgery in the past

• Planned Pregnancy

• Pacemaker

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Glucose Intolerance
• Overweight

Intervention

Behavioral:
• interdisciplinary intervention or meeting-seminars
one-year individualized interdisciplinary weight loss program vs. small group seminars on healthy lifestyle

Locations

Country	Name	City	State
Canada	Centre de Recherche Clinique (CRC), Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Université de Sherbrooke	Ministere de la Sante et des Services Sociaux, Novonordisk endocrine fellowship program

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a weight loss of 7% in at least 19% of the subjects		one year	No
Primary	reduced body weight of at least 5.6 kg in at least 25% of the subjects		one year	No
Primary	an increase in the level of physical activity by at least 150 minutes per week in at least 29% of the subjects		one year	No
Primary	a reduced daily caloric intake of at least 450 kcal/jour in at least 25% of the subjects		one year
Primary	a reduced percentage of the calories introduced in the form of fat of at least 6.6%, in absolute value, in at least 25% of the subjects		one year	No
Secondary	change in insulin sensitivity by HOMA		one year	No
Secondary	change in insulin secretion during an OGTT by deconvolution of plasma c-peptide		one year	No
Secondary	change in beta cell function by calculation of the disposition index		one year	No
Secondary	change in insulin-mediated suppression of plasma non-esterified fatty acids during an OGTT		one year	No
Secondary	relation between weight loss and change in insulin sensitivity, beta cell function, and insulin-mediated suppression of plasma non-esterified fatty acids		one year	No