Reprometabolic Syndrome Mediates Subfertility in Obesity
Sponsor: National Center for Advancing Translational Sciences (NCATS)
This NA trial investigates Hyperinsulinemia and Hypogonadotropic Hypogonadotropism and is currently ongoing. National Center for Advancing Translational Sciences (NCATS) leads this study, which shows 20 recorded versions since 2016 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)Before any of the well-known adverse effects in pregnancy2,3, obesity causes a relatively hypogonadotropic hypogonadal phenotype. Reduced LH, FSH, estradiol (E2) and progesterone secretion are well documented during the menstrual cycles of obese women compared to normal weight women (NWW).4,5. Decreased gonadotropin secretion associated with obesity is related to reduced pituitary sensitivity to GnRH6. This reduction in pituitary sensitivity suggests mediation by circulating factors such as cytokines, insulin, or other pro-inflammatory signals known to be elevated in obesity. We have recently discovered that the combination of hyperinsulinemia and circulating free fatty acids (FFAs), but neither agent alone, can acutely decrease gonadotropin secretion in NWW as well as men, establishing a direct causal linkage for the central hypothesis of this proposal: that chronic pituitary suppression partially mediates obesity related subfertility. Our working model is that the combination of excess, possibly pro-inflammatory (omega-6) circulating FFAs and insulin resistance associated with obesity, cause decreased pituitary sensitivity to GnRH, with a resulting relative sex steroid deficit that further exacerbates the obese phenotype. We have named this phenotype the reprometabolic syndrome. We propose to examine the interrelationships among obesity, reproductive dysfunction and metabolic dysfunction in a mechanistic fashion. We will induce the hypogonadotropic hypogonadal phenotype...
Before any of the well-known adverse effects in pregnancy2,3, obesity causes a relatively hypogonadotropic hypogonadal phenotype. Reduced LH, FSH, estradiol (E2) and progesterone secretion are well documented during the menstrual cycles of obese women compared to normal weight women (NWW).4,5. Decreased gonadotropin secretion associated with obesity is related to reduced pituitary sensitivity to GnRH6. This reduction in pituitary sensitivity suggests mediation by circulating factors such as cytokines, insulin, or other pro-inflammatory signals known to be elevated in obesity. We have recently discovered that the combination of hyperinsulinemia and circulating free fatty acids (FFAs), but neither agent alone, can acutely decrease gonadotropin secretion in NWW as well as men, establishing a direct causal linkage for the central hypothesis of this proposal: that chronic pituitary suppression partially mediates obesity related subfertility. Our working model is that the combination of excess, possibly pro-inflammatory (omega-6) circulating FFAs and insulin resistance associated with obesity, cause decreased pituitary sensitivity to GnRH, with a resulting relative sex steroid deficit that further exacerbates the obese phenotype. We have named this phenotype the reprometabolic syndrome. We propose to examine the interrelationships among obesity, reproductive dysfunction and metabolic dysfunction in a mechanistic fashion. We will induce the hypogonadotropic hypogonadal phenotype of obesity in NWW, who will be primed with a high-fat diet (HFD) designed to increase circulating FFAs and produce short-term insulin resistance and higher insulin levels.1,7-11 Before and after priming, we will test the additive effects of lipid excess, insulin, and inflammation on the reproductive and metabolic axes.
Status Flow
Change History
20 versions recorded-
Mar 2026 — Present [monthly]
Active Not Recruiting NA
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Jan 2026 — Present [monthly]
Active Not Recruiting NA
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Jun 2025 — Mar 2026 [monthly]
Active Not Recruiting NA
Status: Completed → Active Not Recruiting
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Dec 2024 — Jun 2025 [monthly]
Completed NA
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Sep 2024 — Dec 2024 [monthly]
Completed NA
▶ Show 15 earlier versions
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Jul 2024 — Sep 2024 [monthly]
Completed NA
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Jul 2023 — Jul 2024 [monthly]
Completed NA
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Feb 2022 — Jul 2023 [monthly]
Completed NA
Status: Active Not Recruiting → Completed
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Jan 2022 — Feb 2022 [monthly]
Active Not Recruiting NA
Status: Recruiting → Active Not Recruiting
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Nov 2021 — Jan 2022 [monthly]
Recruiting NA
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Sep 2021 — Nov 2021 [monthly]
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Jan 2021 — Sep 2021 [monthly]
Recruiting NA
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Sep 2020 — Jan 2021 [monthly]
Recruiting NA
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Feb 2020 — Sep 2020 [monthly]
Recruiting NA
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Nov 2019 — Feb 2020 [monthly]
Recruiting NA
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Jun 2019 — Nov 2019 [monthly]
Recruiting NA
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Jul 2018 — Jun 2019 [monthly]
Recruiting NA
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Jun 2018 — Jul 2018 [monthly]
Recruiting NA
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Feb 2017 — Jun 2018 [monthly]
Recruiting NA
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Jan 2017 — Feb 2017 [monthly]
Recruiting NA
First recorded
Jun 2016
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- National Center for Advancing Translational Sciences (NCATS)
- University of Colorado, Denver
For direct contact, visit the study record on ClinicalTrials.gov .