MenopauseNCT02076932
Effects of Physical Training on Adipose Tissue Metabolism and Insulin Sensitivity in the Menopausal Transition Phase
A study testing Spinning in people with Menopause and Insulin Resistance, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 57 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Insulin Resistance, Body Composition, Beneficial
- What is being tested?
- Spinning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 57 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Smoking
- Excessive alcohol intake
- Regular medication including hormone replacement treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Training Intervention Study in Late Pre- and Early Postmenopausal Women Investigating the Changes in Adipose Tissue Metabolism and Peripheral Insulin Sensitivity
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.
- Conditions
- Menopause, Insulin Resistance, Body Composition, Beneficial
- Being tested
- Spinning
- Medical subject headings
- Insulin Resistance, Glucocorticoid Receptor Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpinningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Premenopausal women | Active comparator | The premenopausal women will be attending Spinning classes. Receives: Behavioral: Spinning |
| Postmenopausal Women | Experimental | The postmenopausal women will be attending Spinning classes. Receives: Behavioral: Spinning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin stimulated uptake of glucose in adipose tissue
Measured by Positron Emission Tomography-Computed tomography (PET/CT)
Measured: Baseline and 3 months
Hyperinsulinemic euglycemic clamp
Glucose metabolized (mg/kg/min)
Measured: Baseline and 3 months
Adipose tissue distribution
Accessed by Magnetic Resonance Imaging (MRI).
Measured: Baseline and 3 months
Secondary outcomes (11)
Central insulin sensitivity
Fasting plasma insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test
Measured: Baseline and 3 months
Maximal oxygen uptake (ml/O2/kg/min)
Measured using indirect calorimetry and an incremental bicycle protocol
Measured: Baseline and 3 months
Metabolic syndrome
As measured by high density lipoprotein, triglycerides, waist circumference, blood pressure, mean arterial pressure, fasting glucose and composite metabolic syndrome scores
Measured: Baseline and 3 months
Health related quality of life
Measured using questionaries, semi-structured interviews and observations
Measured: Baseline and 3 months
Anthropometry
Measured using dual x-ray absorptiometry, height, weight, waist and hip circumference, sagittal abdominal height
Measured: Baseline and 3 months
Skeletal muscle biopsy
Biochemical, proteomics, metabolomics, genomics and morphological analyses
Measured: Baseline and 3 months
Abdominal subcutaneous adipose tissue biopsy
Biochemical, proteomics, metabolomics, genomics and morphological analyses
Measured: Baseline and 3 months
Resting metabolic rate
Will be measured by indirect calorimetry
Measured: Baseline and 3 months
Physical activity level and duration of sleep
Daily activity and duration of sleep will be recorded during one week using Actibelt® and self reporting
Measured: Baseline and 3 months
Microdialysis
Adipose tissue microdialysis
Measured: Baseline and 3 months
Femoral subcutaneous adipose tissue biopsy
Biochemical, proteomics, metabolomics, genomics and morphological analyses
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Glostrup University Hospital, Copenhagen
- Responsible party
- Principal investigator, Bente Merete Stallknecht, University of Copenhagen
- Investigators
- Ylva Hellsten, Proff., Principal investigator, University of CopenhagenBente M Stallknecht, Proff. MD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076932
- Sponsor's protocol ID
- CWS menopause, adipose tissue
- Status last verified
- May 2016
- First submitted
- 24 Feb 2014
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Training Intervention Study in Late Pre- and Early Postmenopausal Women Investigating the Changes in Adipose Tissue Metabolism and Peripheral Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT02076932
- Acronym / sponsor ID
- CWS menopause, adipose tissue
- Conditions
- Menopause, Insulin Resistance, Body Composition, Beneficial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Glostrup University Hospital, Copenhagen
- Study start
- Apr 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 4 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premenopausal women | Active comparator | Behavioral: SpinningThe premenopausal women will be attending Spinning classes. |
| Postmenopausal Women | Experimental | Behavioral: SpinningThe postmenopausal women will be attending Spinning classes. |
Who may qualify
- Ages
- 45 to 57 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- Smoking
- Excessive alcohol intake
- Regular medication including hormone replacement treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpinningAfter 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. | Behavioural | Postmenopausal Women, Premenopausal women |
Primary outcome
Insulin stimulated uptake of glucose in adipose tissue
Time frame: Baseline and 3 months
Measured by Positron Emission Tomography-Computed tomography (PET/CT)
Hyperinsulinemic euglycemic clamp
Time frame: Baseline and 3 months
Glucose metabolized (mg/kg/min)
Adipose tissue distribution
Time frame: Baseline and 3 months
Accessed by Magnetic Resonance Imaging (MRI).
11 secondary outcomes
Central insulin sensitivity
Time frame: Baseline and 3 months
Maximal oxygen uptake (ml/O2/kg/min)
Time frame: Baseline and 3 months
Metabolic syndrome
Time frame: Baseline and 3 months
Health related quality of life
Time frame: Baseline and 3 months
Anthropometry
Time frame: Baseline and 3 months
Skeletal muscle biopsy
Time frame: Baseline and 3 months
Abdominal subcutaneous adipose tissue biopsy
Time frame: Baseline and 3 months
Resting metabolic rate
Time frame: Baseline and 3 months
Physical activity level and duration of sleep
Time frame: Baseline and 3 months
Microdialysis
Time frame: Baseline and 3 months
Femoral subcutaneous adipose tissue biopsy
Time frame: Baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ylva Hellsten, Proff. principal investigator
University of Copenhagen
Bente M Stallknecht, Proff. MD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinning in people with Menopause and Insulin Resistance, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin stimulated uptake of glucose in adipose tissue (time frame: Baseline and 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016.