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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02076932
Enrollment
43
Registered
2014-03-04
Start date
2014-04-30
Completion date
2016-01-31
Last updated
2016-06-01

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

Conditions

Body Composition, Beneficial, Insulin Resistance, Menopause

Brief summary

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.

Interventions

BEHAVIORALSpinning

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.

Sponsors

Rigshospitalet, Denmark
CollaboratorOTHER
Glostrup University Hospital, Copenhagen
CollaboratorOTHER
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 57 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Adipose tissue distributionBaseline and 3 monthsAccessed by Magnetic Resonance Imaging (MRI).
Insulin stimulated uptake of glucose in adipose tissueBaseline and 3 monthsMeasured by Positron Emission Tomography-Computed tomography (PET/CT)
Hyperinsulinemic euglycemic clampBaseline and 3 monthsGlucose metabolized (mg/kg/min)

Secondary

MeasureTime frameDescription
Metabolic syndromeBaseline and 3 monthsAs measured by high density lipoprotein, triglycerides, waist circumference, blood pressure, mean arterial pressure, fasting glucose and composite metabolic syndrome scores
Health related quality of lifeBaseline and 3 monthsMeasured using questionaries, semi-structured interviews and observations
AnthropometryBaseline and 3 monthsMeasured using dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height
Skeletal muscle biopsyBaseline and 3 monthsBiochemical, proteomics, metabolomics, genomics and morphological analyses
Resting metabolic rateBaseline and 3 monthsWill be measured by indirect calorimetry
Physical activity level and duration of sleepBaseline and 3 monthsDaily activity and duration of sleep will be recorded during one week using Actibelt® and self reporting
MicrodialysisBaseline and 3 monthsAdipose tissue microdialysis
Femoral subcutaneous adipose tissue biopsyBaseline and 3 monthsBiochemical, proteomics, metabolomics, genomics and morphological analyses
Abdominal subcutaneous adipose tissue biopsyBaseline and 3 monthsBiochemical, proteomics, metabolomics, genomics and morphological analyses
Central insulin sensitivityBaseline and 3 monthsFasting plasma insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test
Maximal oxygen uptake (ml/O2/kg/min)Baseline and 3 monthsMeasured using indirect calorimetry and an incremental bicycle protocol

Other

MeasureTime frameDescription
Dietary registrationBaseline and 3 monthsDaily food intake for three week days and one week-end day will be reported by the subjects

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026