Reprometabolic Syndrome Mediates Subfertility in Obesity



Status:Recruiting
Conditions:Obesity Weight Loss, Women's Studies, Endocrine, Infertility
Therapuetic Areas:Endocrinology, Reproductive
Healthy:No
Age Range:18 - 38
Updated:6/17/2018
Start Date:June 2016
End Date:March 2020
Contact:Chanel Mansfield
Email:chanel.mansfield@ucdenver.edu
Phone:303-724-6501

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Obesity plays an adverse role at every stage of conception and pregnancy and mounting
evidence implicates relative hypogonadotropic hypogonadism, and reduced menstrual cycle
hormone secretion as likely contributors to the subfertility phenotype and possible
contributors to complications of pregnancy and the developmental origin of adult diseases
such as diabetes and cardiovascular disease. This study will be the first comprehensive
investigation to tie together the patterns of hyperinsulinemia, hyperlipidemia and
inflammation, characteristic of obesity and obesity-caused relative hypogonadotropic
hypogonadotropism and its potential adverse reproductive outcomes. The investigators findings
will be used to inform a subsequent clinical intervention to optimize reproductive outcomes
for obese women and their offspring.


Inclusion Criteria:

- Body Mass Index (BMI) at least 18 but less than 25 kg/m2

- No history of chronic disease affecting hormone production, metabolism, or clearance

- No use of medications known to alter or interact with reproductive hormones or insulin
metabolism (e.g. thiazolidinediones, metformin)

- No use of reproductive hormones within 3 months of enrollment

- Normal prolactin and thyroid stimulating hormone levels at screening

- History of regular menstrual cycles every 25-35 days

- Use of a reliable method of contraception (female or male partner sterilization; intra
uterine device (IUD); abstinence; diaphragm)

- Normal hemoglobin A1c

- Screening hemoglobin >11gm/dl

Exclusion Criteria:

- Women with a baseline dietary assessment indicative of >35% daily calorie consumption
from fat (as calculated based upon initial screening survey) will be excluded, as the
impact of increasing their dietary fat intake may be minimal.

- Women with fasting triglycerides >300mg/dl at screening will be excluded, as they
might be at risk for acute elevation of triglycerides and even pancreatitis if placed
on a high fat diet

- Inability to comply with the protocol. Individuals who travel frequently, or who eat
most of their meals outside of their home will be excluded, as it will be difficult to
impossible for them to comply with the diet, to pick up the food cartons, etc.

- Because high proportions of dairy fat will be needed to attain 48% calories from fat
in the diet, vegans and lactose intolerant individuals will be excluded.

- Pregnant women or women planning to become pregnant will be excluded.
We found this trial at
1
site
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Nanette Santoro, MD
Phone: 303-724-6501
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Aurora, CO
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