Diabetes Prevention In Estrie

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

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.

Study Overview

• Status: Completed
• Conditions: Overweight; Glucose Intolerance
• Intervention / Treatment: Behavioral: interdisciplinary intervention or meeting-seminars

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada
      • Centre de Recherche Clinique (CRC), Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; interdisciplinary weight loss intervention	Behavioral: interdisciplinary intervention or meeting-seminars; one-year individualized interdisciplinary weight loss program vs. small group seminars on healthy lifestyle
Active Comparator: 2; Small group seminars without interdisciplinary intervention	Behavioral: interdisciplinary intervention or meeting-seminars; one-year individualized interdisciplinary weight loss program vs. small group seminars on healthy lifestyle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
a weight loss of 7% in at least 19% of the subjects	one year
reduced body weight of at least 5.6 kg in at least 25% of the subjects	one year
an increase in the level of physical activity by at least 150 minutes per week in at least 29% of the subjects	one year
a reduced daily caloric intake of at least 450 kcal/jour in at least 25% of the subjects	one year
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

Secondary Outcome Measures

Outcome Measure	Time Frame
change in insulin sensitivity by HOMA	one year
change in insulin secretion during an OGTT by deconvolution of plasma c-peptide	one year
change in beta cell function by calculation of the disposition index	one year
change in insulin-mediated suppression of plasma non-esterified fatty acids during an OGTT	one year
relation between weight loss and change in insulin sensitivity, beta cell function, and insulin-mediated suppression of plasma non-esterified fatty acids	one year

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Collaborators: Ministere de la Sante et des Services Sociaux; Novonordisk endocrine fellowship program
• Investigators: Principal Investigator: Marie-France Langlois, MD, Medecine Department, Division of endocrinology, CHUS

Publications and helpful links

General Publications

• Gagnon C, Brown C, Couture C, Kamga-Ngande CN, Hivert MF, Baillargeon JP, Carpentier AC, Langlois MF. A cost-effective moderate-intensity interdisciplinary weight-management programme for individuals with prediabetes. Diabetes Metab. 2011 Nov;37(5):410-8. doi: 10.1016/j.diabet.2011.01.003. Epub 2011 Apr 13.

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: October 7, 2009
• First Submitted That Met QC Criteria: October 7, 2009
• First Posted (Estimate): October 8, 2009

Study Record Updates

• Last Update Posted (Estimate): October 8, 2009
• Last Update Submitted That Met QC Criteria: October 7, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: obesity; overweight; glucose intolerance; pre-diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Body Weight; Hyperglycemia; Glucose Intolerance; Overweight
• Other Study ID Numbers: 04-087