How Menopause Affects Lipid Metabolism in the Visceral Fat Depots

• Conditions: Insulin Sensitivity and Lipid Metabolism
• Interventions: Other: This is an observational study. There are no interventions

• Registration Number: NCT02524457
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2015-08
• Study First Submitted: 2015-08-11
• Study First Submitted QC: 2015-08-13
• Last Update Submitted: 2015-08-13
• Study First Posted: 2015-08-14
• Last Update Posted: 2015-08-14
• Study Start: 2015-09
• Primary Completion: 2018-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Premenopausal	This is an observational study. There are no interventions	Premenopausal women going through gynecological surgery
Postmenopausal + HT	This is an observational study. There are no interventions	Postmenopausal women going through gynecological surgery who has been taking hormone treatment through the past year (as a minimum)
Postmenopausal	This is an observational study. There are no interventions	Postemnopausal women going through gynecological surgery

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity	4 weeks	measured through a hyperinsulinemic euglycemic clamp (Outcome: glucose infusion rate)