deltatrials
Active Not Recruiting NA INTERVENTIONAL 2-arm NCT02653092

Reprometabolic Syndrome Mediates Subfertility in Obesity

Sponsor: National Center for Advancing Translational Sciences (NCATS)

Updated 20 times since 2017 Last updated: Feb 10, 2026 Started: Jun 30, 2016 Primary completion: Dec 11, 2023 Completion: Dec 11, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Jun 2019 · 11 months · monthly snapshot~Jun 2019 – ~Nov 2019 · 5 months · monthly snapshot~Nov 2019 – ~Feb 2020 · 3 months · monthly snapshot~Feb 2020 – ~Sep 2020 · 7 months · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Nov 2021 · 2 months · monthly snapshot~Nov 2021 – ~Jan 2022 · 2 months · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Jul 2023 · 17 months · monthly snapshot~Jul 2023 – ~Jul 2024 · 12 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshot~Dec 2024 – ~Jun 2025 · 6 months · monthly snapshot~Jun 2025 – ~Mar 2026 · 9 months · monthly snapshot~Jan 2026 – present · 3 months · monthly snapshot~Mar 2026 – present · 36 days · monthly snapshot

Change History

20 versions recorded
  1. Mar 2026 — Present [monthly]

    Active Not Recruiting NA

  2. Jan 2026 — Present [monthly]

    Active Not Recruiting NA

  3. Jun 2025 — Mar 2026 [monthly]

    Active Not Recruiting NA

    Status: CompletedActive Not Recruiting

  4. Dec 2024 — Jun 2025 [monthly]

    Completed NA

  5. Sep 2024 — Dec 2024 [monthly]

    Completed NA

Show 15 earlier versions
  1. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  2. Jul 2023 — Jul 2024 [monthly]

    Completed NA

  3. Feb 2022 — Jul 2023 [monthly]

    Completed NA

    Status: Active Not RecruitingCompleted

  4. Jan 2022 — Feb 2022 [monthly]

    Active Not Recruiting NA

    Status: RecruitingActive Not Recruiting

  5. Nov 2021 — Jan 2022 [monthly]

    Recruiting NA

  6. Sep 2021 — Nov 2021 [monthly]

    Recruiting NA

  7. Jan 2021 — Sep 2021 [monthly]

    Recruiting NA

  8. Sep 2020 — Jan 2021 [monthly]

    Recruiting NA

  9. Feb 2020 — Sep 2020 [monthly]

    Recruiting NA

  10. Nov 2019 — Feb 2020 [monthly]

    Recruiting NA

  11. Jun 2019 — Nov 2019 [monthly]

    Recruiting NA

  12. Jul 2018 — Jun 2019 [monthly]

    Recruiting NA

  13. Jun 2018 — Jul 2018 [monthly]

    Recruiting NA

  14. Feb 2017 — Jun 2018 [monthly]

    Recruiting NA

  15. 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

Sponsor contact:
  • National Center for Advancing Translational Sciences (NCATS)
  • University of Colorado, Denver
Data source: University of Colorado, Denver

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations