Effects of a lifestyle modification program in overweight and obese women at risk of diabetes in the early menopause stage

Completed

Conditions: Obesity, menopause, diabetes
Nutritional, Metabolic, Endocrine
Non-insulin dependent diabetes mellitus

Registration Number: ISRCTN25796154

Lead Sponsor: niversity of Ottawa (Canada)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 120

Inclusion Criteria

Current inclusion criteria as of 10/01/2012
Participants - inclusion criteria
1. Women aged 45 years or older.
2. Overweight or obese (BMI higher than 27 kg/m2 and lower than 40 kg/m2)
3. Women with menstrual irregularities or without menses for 48 months or less
4. Non-smokers
5. Low to moderate alcohol consumers (less than 2 drinks/day)
6. Sedentary (less than 30 minutes of exercise per week)
7. Total risk score =12 from the type 2 diabetes risk assessment form

Previous inclusion criteria
1. Women aged 45-55 years
2. Overweight or obese (BMI higher than 27 kg/m2 and lower than 40 kg/m2)
3. Women without menses within the last 6 to 18 months
4. Non-smokers
5. Low to moderate alcohol consumers (less than 2 drinks/day)
6. Sedentary (less than 30 minutes of exercise per week)
7. Total risk score =12 from the type 2 diabetes risk assessment form

Exclusion Criteria

1. Pregnant or who plan to become pregnant
2. Women with medical problems and/or are taking medications which may impact on menopause or on study outcome
3. Women who had hysterectomy or bi-lateral ovariectomy
4. Known diabetes
5. Known coronary heart disease

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Total fat mass, measured at baseline, 4 and 12 months<br>2. Dual-photon x-ray (DXA) will be used to measure the following:<br>2.1. Body weight <br>2.2. Height <br>2.3. Bone density<br>2.4. Percent fat<br>2.5. Percent lean body mass<br>Each subject's scan will be divided into several regions: arms, legs, trunk (pelvis, spine and ribs) and head using an on-screen image of the subject's skeleton and specific skeletal landmarks to obtain regional body composition.

Secondary Outcome Measures