NCT02653092Active, not recruiting
Reprometabolic Syndrome Mediates Subfertility in Obesity
Source: ClinicalTrials.gov · Last updated 2 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 84 (actual)
- First submitted
- 5 Jan 2016
- Start date
- Jun 2016
- Primary completion date
- 11 Dec 2023
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Obesity
- NCT number
- NCT02653092
What you commit to
- Study type: Interventional
- Participants enrolled: 84
- From Jun 2016 to the primary completion date, 11 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 38 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Denver Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.