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Completed

NCT Number: NCT02076932

Effects of Physical Training on Adipose Tissue Metabolism and Insulin Sensitivity in the Menopausal Transition Phase

The purpose of this study is to determine if physical exercise reduces the adverse changes in adipose tissue metabolism and insulin sensitivity that occurs in women during the menopausal transition.

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Key information

Conditions

Menopause Body Composition, Beneficial Glucocorticoid Receptor Deficiency Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year–57 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department og Biomedical Sciences

Copenhagen N, 2200, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Premenopausal OR Postmenopausal (45-57 years)
  • No chronical Diseases
  • BMI > 18,5 and < 30
  • Sedentary (no regular physical activity the last 2 years)
  • Either regular bleeding (premenopausal) OR no menstruation for at least 2 years (postmenopausal)
  • Plasma measurements:

Premenopausal: estradiol > 0.20nmol/l, Follicle Stimulating Hormone < 22 IU/l and progesterone > 2.5 nmol/l Postmenopausal: estradiol < 0.20nmol/l, Follicle Stimulating Hormone > 22 IU/l and progesterone from 0.3-2.5 nmol/l

Exclusion criteria

  • Smoking
  • Excessive alcohol intake
  • Regular medication including hormone replacement treatment

Treatment and study plan

Spinning

Behavioral

After the baseline studies, the women will perform Spinning three times a week. Two of the sessions are performed on our location by trained instructors and the third training is self-training in a local fitness center where we provide free membership. All trainings are heart rate monitored.

Primary outcomes

  1. Insulin stimulated uptake of glucose in adipose tissue

    Time frame: Baseline and 3 months

    Measured by Positron Emission Tomography-Computed tomography (PET/CT)

  2. Hyperinsulinemic euglycemic clamp

    Time frame: Baseline and 3 months

    Glucose metabolized (mg/kg/min)

  3. Adipose tissue distribution

    Time frame: Baseline and 3 months

    Accessed by Magnetic Resonance Imaging (MRI).

Secondary outcomes

  1. Central insulin sensitivity

    Time frame: Baseline and 3 months

    Fasting plasma insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test

  2. Maximal oxygen uptake (ml/O2/kg/min)

    Time frame: Baseline and 3 months

    Measured using indirect calorimetry and an incremental bicycle protocol

  3. Metabolic syndrome

    Time frame: Baseline and 3 months

    As measured by high density lipoprotein, triglycerides, waist circumference, blood pressure, mean arterial pressure, fasting glucose and composite metabolic syndrome scores

  4. Health related quality of life

    Time frame: Baseline and 3 months

    Measured using questionaries, semi-structured interviews and observations

  5. Anthropometry

    Time frame: Baseline and 3 months

    Measured using dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height

  6. Skeletal muscle biopsy

    Time frame: Baseline and 3 months

    Biochemical, proteomics, metabolomics, genomics and morphological analyses

  7. Abdominal subcutaneous adipose tissue biopsy

    Time frame: Baseline and 3 months

    Biochemical, proteomics, metabolomics, genomics and morphological analyses

  8. Resting metabolic rate

    Time frame: Baseline and 3 months

    Will be measured by indirect calorimetry

  9. Physical activity level and duration of sleep

    Time frame: Baseline and 3 months

    Daily activity and duration of sleep will be recorded during one week using Actibelt® and self reporting

  10. Microdialysis

    Time frame: Baseline and 3 months

    Adipose tissue microdialysis

  11. Femoral subcutaneous adipose tissue biopsy

    Time frame: Baseline and 3 months

    Biochemical, proteomics, metabolomics, genomics and morphological analyses

Other outcomes

  1. Dietary registration

    Time frame: Baseline and 3 months

    Daily food intake for three week days and one week-end day will be reported by the subjects

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Glostrup University Hospital, Copenhagen
  • Rigshospitalet, Denmark

Registry information

Official study title

A Training Intervention Study in Late Pre- and Early Postmenopausal Women Investigating the Changes in Adipose Tissue Metabolism and Peripheral Insulin Sensitivity

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 4, 2014
Registry last updated
Jun 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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