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Trial record 36 of 161 for:    Recruiting, Not yet recruiting, Available Studies | menopause

How Menopause Affects Lipid Metabolism in the Visceral Fat Depots

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ClinicalTrials.gov Identifier: NCT02524457
Recruitment Status : Not yet recruiting
First Posted : August 14, 2015
Last Update Posted : August 14, 2015
Sponsor:
Information provided by (Responsible Party):
Anders Rasmussen Rinnov, Rigshospitalet, Denmark

Brief 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 relation to the menopausal transition.

Condition or disease Intervention/treatment
Insulin Sensitivity and Lipid Metabolism Other: This is an observational study. There are no interventions

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 Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: How Menopause Affects Lipid Metabolism in the Visceral Fat Depots
Study Start Date : September 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Group/Cohort Intervention/treatment
Premenopausal
Premenopausal women going through gynecological surgery
Other: This is an observational study. There are no interventions
Postmenopausal
Postemnopausal women going through gynecological surgery
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)
Other: This is an observational study. There are no interventions



Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: 4 weeks ]
    measured through a hyperinsulinemic euglycemic clamp (Outcome: glucose infusion rate)


Biospecimen Retention:   Samples With DNA
blood and fat biopsies


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women from 45-55 years of age undergoing gynecological surgery for benign reasons.
Criteria

Inclusion Criteria:

  • women
  • 45-55 years old
  • for HT treated women (HT more than 1 year)

Exclusion Criteria:

  • Infections during the last month
  • chronic disease
  • claustrophobia
  • smoking
  • Alcoholic intake > 14 servings
  • hysterectomy before menopause
  • oophorectomized
  • early menopause (before 40 yrs)
  • BMI > 30

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02524457


Contacts
Contact: Julie Abildgaard, MD +4535457190 julie.abildgaard.01@regionh.dk

Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Julie Abildgaard, MD Rigshospitalet, Denmark