Clinical Trial

Acupuncture or Metformin for Insulin Resistance in Women With PCOS

Study acronym: PIAII
Recruiting Phase 2
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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.
Summary
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).
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2016-01-05; most recent amendment 2024-10-07.
Trial Details
NCT Number NCT02647827
Lead Sponsor Karolinska Institutet
Collaborators: Karolinska University Hospital, Peking University
Conditions Polycystic Ovary Syndrome, Insulin Resistance, Hyperandrogenism
Enrollment 303 participants
Start Date 2015-12
Primary Completion 2025-06 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2024-10-09