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The effects of equivalent weight loss with or without exercise programme on breast cancer risk biomarkers in postmenopausal women: the SHAPE-2 study.

The effects of equivalent weight loss with or without exercise programme on breast cancer risk biomarkers in postmenopausal women: the SHAPE-2 study. - SHAPE-2 (Sex Hormones And Physical Exercise) study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38377
Enrollment
250
Registered
2012-02-14
Start date
2012-03-13
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer breast neoplasm

Interventions

During the run-in period, all women will follow a weight maintenance diet according to guidelines for healthy nutrition (50-60% carbohydrate, 15-20%protein and 20-35% fat) under supervision of a die

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Female. 50-69 years of age. Postmenopausal (>12 months after last menses). BMI 25-35 kg/m2. Inactive (4 MET)). Willing to be randomly assigned to one of the three study arms.

Exclusion criteria

Exclusion criteria: Use of sex hormones in the past 12 months. Suffering from breastcancer (in medical history) or other cancers in the last 5 years, except for non-melanoma skin cancers. Suffering from type II diabetes mellitus or other endocrine related diseases. Smoker.

Design outcomes

Primary

MeasureTime frame
Sex-hormone levels: estradiol, estrone, testosterone, sex hormone binding globulin (SHBG).

Secondary

MeasureTime frame
Physical fitness, anthropometrics, the amount of total body fat (DEXA scan) and abdominal fat (MRI). We also measure lifestyle factors: i.e. habitual physical activity, dietary pattern, alcohol consumption and medication use.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)