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Acupuncture or Metformin for Insulin Resistance in Women With PCOS

Study acronym: PIAII
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 9, 2024 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Dec 2024 to Jun 2025
    • Study completion date: Dec 2025 to Jun 2026
    • Site contacts updated at 1 of 2 sites
    v8
  2. Primary completion date: Dec 2023 to Dec 2024
    • Study completion date: Dec 2024 to Dec 2025
    v7
  3. Primary completion date: Dec 2021 to Dec 2023
    • Study completion date: Dec 2022 to Dec 2024
    v6
  4. Primary completion date: Dec 2020 to Dec 2021
    • Study completion date: Dec 2021 to Dec 2022
    v5
  5. Primary completion date: Dec 2018 to Dec 2020
    • Study completion date: Dec 2019 to Dec 2021
    v4
  6. 2 versions Re-verified since Aug 16, 2017, no change to tracked fieldsv2-v3
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The hypothesis is that acupuncture is equally effective as metformin (both treatments combined with lifestyle management) in improving whole body glucose homeostasis in insulin resistant women with polycystic ovary syndrome (PCOS), and that both are superior to lifestyle management alone. The investigators hypothesize that acupuncture and metformin induce ovulation and improve hyperandrogenism, as well as health related quality of life (HRQoL) and symptoms of anxiety and depression. Although equally effective (acupuncture and metformin), the investigators hypothesize that acupuncture is associated with less negative side-effects. The investigators also hypothesize that these treatments have the potential to restore epigenetic and molecular alterations in target tissues (endometrial-, adipose-, and skeletal muscle tissue) and thus have the potential to prevent the development of type 2 diabetes (T2D).
Trial Details
NCT Number NCT02647827
Lead Sponsor Karolinska Institutet
Collaborators: Karolinska University Hospital, Peking University
Conditions
(from sponsor)		 Polycystic Ovary Syndrome, Insulin Resistance, Hyperandrogenism
Related terms Hyperandrogenism, Insulin Resistance, Polycystic Ovary Syndrome
Enrollment 303 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov