Clinical trial NCT00991549: Diabetes Prevention In Estrie
Official title: Comparative Evaluation of the Effectiveness of 2 Available Resources in Estrie, for the Prevention of Type 2 Diabetes in High-risk Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Glucose Intolerance
Keywords: overweight
obesity
glucose intolerance
pre-diabetes
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Ministere de la Sante et des Services Sociaux
name: Novonordisk endocrine fellowship program
First posted: 2009-10-08
Enrollment: 53
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: a weight loss of 7% in at least 19% of the subjects
timeFrame: one year
measure: reduced body weight of at least 5.6 kg in at least 25% of the subjects
timeFrame: one year
measure: an increase in the level of physical activity by at least 150 minutes per week in at least 29% of the subjects
timeFrame: one year
measure: a reduced daily caloric intake of at least 450 kcal/jour in at least 25% of the subjects
timeFrame: one year
measure: 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
timeFrame: one year
Secondary outcomes:
measure: change in insulin sensitivity by HOMA
timeFrame: one year
measure: change in insulin secretion during an OGTT by deconvolution of plasma c-peptide
timeFrame: one year
measure: change in beta cell function by calculation of the disposition index
timeFrame: one year
measure: change in insulin-mediated suppression of plasma non-esterified fatty acids during an OGTT
timeFrame: one year
measure: relation between weight loss and change in insulin sensitivity, beta cell function, and insulin-mediated suppression of plasma non-esterified fatty acids
timeFrame: one year
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de Recherche Clinique (CRC), Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Medecine department, Division of endocrinology, CHUS
name: Marie-France Langlois, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.