Clinical Trials Directory

Trials / Terminated

TerminatedNCT03396978

The Influence of Gonadal Hormone Suppression on Adipocyte Lineage and the Microbiome

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
5 (actual)
Sponsor
University of Colorado, Denver · Academic / Other
Sex
Female
Age
18 Years – 50 Years
Healthy volunteers
Accepted

Summary

This research study plans to learn more about the role of female sex hormones on adipose tissue (or fat) and the gut microbiome (or the organisms that are in your digestive tract). The rationale for this study is that the rate at which women gain fat (especially in the stomach region) increases after menopause. It is thought to be due to the loss of estrogen because post-menopausal women who take estrogen gain less weight than those who do not take estrogen. Gut bacteria process estrogen and help determine the types of estrogen that circulate in the body. These bacteria can be changed with lifestyle factors such as diet, and may therefore, also affect the risk of diseases that are more common in women after menopause i.e., cardiovascular disease and cancer. In this study the investigators will obtain fat biopsies before and after 6 months of ovarian hormone suppression to measure how the fat cells change with the loss of female sex hormones (e.g., medical menopause). The investigators will also obtain stool and urine samples before and every month during the study to measure changes in the microbiome.

Conditions

Interventions

TypeNameDescription
OTHERGnRHagOvarian Hormone Suppression - the purpose of the intervention is not to study the drug, but the impact of the loss of ovarian hormones.

Timeline

Start date
2018-01-11
Primary completion
2019-12-18
Completion
2019-12-18
First posted
2018-01-11
Last updated
2021-08-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03396978. Inclusion in this directory is not an endorsement.