drugset / Trial / NCT02647827

Acupuncture or Metformin for Insulin Resistance in Women With PCOS

NCT02647827 ↗

RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2015-12
Primary completion
2025-06
Completion
2026-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metformin Small molecule 500 mg Oral