Insulin Sensitivity and Lipid MetabolismNCT02524457
How Menopause Affects Lipid Metabolism in the Visceral Fat Depots
An observational study of Insulin Sensitivity and Lipid Metabolism, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
The purpose of the study is to describe the molecular mechanisms related to an increased visceral fat mass and changed T-cell homeostasis. the project is expected to add new knowledge to the field of metabolic diseases after menopause and increase the focus of how lipid affects the development of metabolic disease in… Read more about this study
- Who is it for?
- Ages 45 to 55 years, women only
- Conditions the study is for
- Insulin Sensitivity and Lipid Metabolism
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Sep 2020
- Phase
- Observational
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Women from 45-55 years of age undergoing gynecological surgery for benign reasons.
Who may be able to join
- women
- 45-55 years old
- for HT treated women (HT more than 1 year)
Who cannot join
- Infections during the last month
- chronic disease
- claustrophobia
- smoking
- Alcoholic intake > 14 servings
- hysterectomy before menopause
Show all 9Show fewer
- oophorectomized
- early menopause (before 40 yrs)
- BMI > 30
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of the study is to describe the molecular mechanisms related to an increased visceral fat mass and changed T-cell homeostasis. the project is expected to add new knowledge to the field of metabolic diseases after menopause and increase the focus of how lipid affects the development of metabolic disease in relation to the menopausal transition.
Read the detailed description
The study is a cross sectional study including 60 women between 45 and 55 years of age. Investigators aim to include 20 premenopausal women, 20 postmenopausal women and 20 postmenopausal women taking hormone treatment (HT). All the women are going through gynecological surgery for benign reasons. During the operation investigators will take a visceral fat biopsy from the omentum.
maximally 1 month before- or after the operation the subject will meet at the lab for further testing, including:
- Health examination
- Blood samples
- OGTT
- DXA scan
- VO2 max testing
- MRI of the abdomen
- hyperinsulinemic euglycemic clamp
- Conditions
- Insulin Sensitivity and Lipid Metabolism
- Being tested
- This is an observational study. There are no interventions
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an observational study. There are no interventionsOther
| Study group | Role | What they receive |
|---|---|---|
| Premenopausal | Premenopausal women going through gynecological surgery Receives: Other: This is an observational study. There are no interventions | |
| Postmenopausal | Postemnopausal women going through gynecological surgery Receives: Other: This is an observational study. There are no interventions | |
| Postmenopausal + HT | Postmenopausal women going through gynecological surgery who has been taking hormone treatment through the past year (as a minimum) Receives: Other: This is an observational study. There are no interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
measured through a hyperinsulinemic euglycemic clamp (Outcome: glucose infusion rate)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2018 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Insulin Sensitivity and Lipid MetabolismStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Rasmussen Rinnov, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Julie Abildgaard, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524457
- Sponsor's protocol ID
- H-3-2014-096
- Status last verified
- Aug 2015
- First submitted
- 11 Aug 2015
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abildgaard J, Pedersen AT, Green CJ, Harder-Lauridsen NM, Solomon TP, Thomsen C, Juul A, Pedersen M, Pedersen JT, Mortensen OH, Pilegaard H, Pedersen BK, Lindegaard B. Menopause is associated with decreased whole body fat oxidation during exercise. Am J Physiol Endocrinol Metab. 2013 Jun 1;304(11):E1227-36. doi: 10.1152/ajpendo.00492.2012. Epub 2013 Apr 2.
PubMed 23548615Abildgaard J, Henstridge DC, Pedersen AT, Langley KG, Scheele C, Pedersen BK, Lindegaard B. In vitro palmitate treatment of myotubes from postmenopausal women leads to ceramide accumulation, inflammation and affected insulin signaling. PLoS One. 2014 Jul 7;9(7):e101555. doi: 10.1371/journal.pone.0101555. eCollection 2014.
PubMed 25000528
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Menopause Affects Lipid Metabolism in the Visceral Fat Depots
- ClinicalTrials.gov ID
- NCT02524457
- Acronym / sponsor ID
- H-3-2014-096
- Conditions
- Insulin Sensitivity and Lipid Metabolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 14 Aug 2015 (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 the study is to describe the molecular mechanisms related to an increased visceral fat mass and changed T-cell homeostasis. the project is expected to add new knowledge to the field of metabolic diseases after menopause and increase the focus of how lipid affects the development of metabolic disease in relation to the menopausal transition.
Detailed description
The study is a cross sectional study including 60 women between 45 and 55 years of age. Investigators aim to include 20 premenopausal women, 20 postmenopausal women and 20 postmenopausal women taking hormone treatment (HT). All the women are going through gynecological surgery for benign reasons. During the operation investigators will take a visceral fat biopsy from the omentum.
maximally 1 month before- or after the operation the subject will meet at the lab for further testing, including:
- Health examination
- Blood samples
- OGTT
- DXA scan
- VO2 max testing
- MRI of the abdomen
- hyperinsulinemic euglycemic clamp
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Premenopausal | – | Other: This is an observational study. There are no interventionsPremenopausal women going through gynecological surgery |
| Postmenopausal | – | Other: This is an observational study. There are no interventionsPostemnopausal women going through gynecological surgery |
| Postmenopausal + HT | – | Other: This is an observational study. There are no interventionsPostmenopausal women going through gynecological surgery who has been taking hormone treatment through the past year (as a minimum) |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women from 45-55 years of age undergoing gynecological surgery for benign reasons.
Key inclusion criteria (3 listed)
- women
- 45-55 years old
- for HT treated women (HT more than 1 year)
Key exclusion criteria (9 listed)
- Infections during the last month
- chronic disease
- claustrophobia
- smoking
- Alcoholic intake > 14 servings
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 |
|---|---|---|
| This is an observational study. There are no interventions | Other | Postmenopausal, Postmenopausal + HT, Premenopausal |
Primary outcome
Insulin sensitivity
Time frame: 4 weeks
measured through a hyperinsulinemic euglycemic clamp (Outcome: glucose infusion rate)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2015.
- Background: PubMed 23548615Abildgaard J, Pedersen AT, Green CJ, Harder-Lauridsen NM, Solomon TP, Thomsen C, Juul A, Pedersen M, Pedersen JT, Mortensen OH, Pilegaard H, Pedersen BK, Lindegaard B. Menopause is associated with decreased whole body fat oxidation during exercise. Am J Physiol Endocrinol Metab. 2013 Jun 1;304(11):E1227-36. doi: 10.1152/ajpendo.00492.2012. Epub 2013 Apr 2.
- Background: PubMed 25000528Abildgaard J, Henstridge DC, Pedersen AT, Langley KG, Scheele C, Pedersen BK, Lindegaard B. In vitro palmitate treatment of myotubes from postmenopausal women leads to ceramide accumulation, inflammation and affected insulin signaling. PLoS One. 2014 Jul 7;9(7):e101555. doi: 10.1371/journal.pone.0101555. eCollection 2014.
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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.
Julie Abildgaard, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Sensitivity and Lipid Metabolism, run by Copenhagen University Hospital, Rigshospitalet.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Abildgaard, MD (+4535457190, julie.abildgaard.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02524457, which also lists 2 linked publications.
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 14 Aug 2015.