Clinical trial

Reprometabolic Syndrome Mediates Subfertility in Obesity

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT02653092

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 38 Years
SexFemale
Healthy volunteersAccepted
ConditionObesity, Infertility, Hypogonadotropic Hypogonadotropism, Hyperinsulinemia

Full registry criteria

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.

Treatments and study arms

Insulin

Drug

Intralipid

Drug

Dextrose

Drug

Heparin

Drug

GnRH

Drug

Hyperinsulinemic Euglycemic Clamp

Procedure

Primary outcomes

Change in LH Pulse Amplitude Before and After Acute or Chronic FFA AdministrationFirst 4 hours of the frequent blood sampling study before and after FFA administration

LH-Luteinizing Hormone Pulse Amplitude before and after administration of FFAs. This is a measure of the post supplementation frequent blood sampling session and the baseline session.

Change in Steady State Amount of Glucose Metabolized at the Set Insulin Infusion Rate Under Euglycemic Conditions30 minutes

Primary outcome will be M, which represents the steady state amount of glucose metabolized at the set insulin infusion rate under euglycemic conditions, which is equal to the glucose infused when the participant is euglycemic during the second stage of the HEC49. The final 30 minutes of the clamp period will be considered steady state. Glucose concentrations will be determined with the glucose oxidase method (Beckman Glucose Analyzer 2; Beckman Instruments, Fullerton, CA), while ELISA methods will be used for insulin measurements (Alpco, Salem, NH).

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Colorado Denver🇺🇸 Aurora, Colorado, United States