Clinical trial NCT02076932: Effects of Physical Training on Adipose Tissue Metabolism and Insulin Sensitivity in the Menopausal Transition Phase
Official title: A Training Intervention Study in Late Pre- and Early Postmenopausal Women Investigating the Changes in Adipose Tissue Metabolism and Peripheral Insulin Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Insulin Resistance
Body Composition, Beneficial
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Glostrup University Hospital, Copenhagen
First posted: 2014-03-04
Enrollment: 43
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 57
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Insulin stimulated uptake of glucose in adipose tissue
timeFrame: Baseline and 3 months
measure: Hyperinsulinemic euglycemic clamp
timeFrame: Baseline and 3 months
measure: Adipose tissue distribution
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Central insulin sensitivity
timeFrame: Baseline and 3 months
measure: Maximal oxygen uptake (ml/O2/kg/min)
timeFrame: Baseline and 3 months
measure: Metabolic syndrome
timeFrame: Baseline and 3 months
measure: Health related quality of life
timeFrame: Baseline and 3 months
measure: Anthropometry
timeFrame: Baseline and 3 months
measure: Skeletal muscle biopsy
timeFrame: Baseline and 3 months
measure: Abdominal subcutaneous adipose tissue biopsy
timeFrame: Baseline and 3 months
measure: Resting metabolic rate
timeFrame: Baseline and 3 months
measure: Physical activity level and duration of sleep
timeFrame: Baseline and 3 months
measure: Microdialysis
timeFrame: Baseline and 3 months
measure: Femoral subcutaneous adipose tissue biopsy
timeFrame: Baseline and 3 months
Other outcomes:
measure: Dietary registration
timeFrame: Baseline and 3 months
Locations:
city: Copenhagen N
country: Denmark
facility: Department og Biomedical Sciences
Study officials:
affiliation: University of Copenhagen
name: Ylva Hellsten, Proff.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen
name: Bente M Stallknecht, Proff. MD
role: PRINCIPAL_INVESTIGATOR
References: