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Acupuncture or Metformin for Insulin Resistance in Women with Polycystic Ovary Syndrome: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514505-64-01
Acronym
PIAII
Enrollment
353
Registered
2024-10-17
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovary syndrome

Brief summary

Changes in insulin sensitivity after 16 weeks of intervention as measured by HOMA-IR, by the insulin response to glucose assessed by calculating the area under the curve (AUCinsulin) during the oral glucose tolerance test (OGTT), and by glucose regulation (assessed by analyzing Hba1c levels).

Detailed description

After 4 months of intervention: • Changes in secondary metabolic measures, including fasting insulin, c-peptide, glucose, and adipokines, calculation of HOMA-B (i.e. the Islet β-cell function) and the c-peptide index, assessment of the adipokines and lipid profile, body size and proportions and body fat distribution. • Changes in gene expression and DNA methylation profiles related to insulin sensitivity in fat, muscle and endometrial tissue biopsies, and biomarkers in whole blood. • Changes in

Interventions

DRUGMetformin Actavis 500 mg filmdragerad tablett

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Changes in insulin sensitivity after 16 weeks of intervention as measured by HOMA-IR, by the insulin response to glucose assessed by calculating the area under the curve (AUCinsulin) during the oral glucose tolerance test (OGTT), and by glucose regulation (assessed by analyzing Hba1c levels).

Secondary

MeasureTime frame
After 4 months of intervention: • Changes in secondary metabolic measures, including fasting insulin, c-peptide, glucose, and adipokines, calculation of HOMA-B (i.e. the Islet β-cell function) and the c-peptide index, assessment of the adipokines and lipid profile, body size and proportions and body fat distribution. • Changes in gene expression and DNA methylation profiles related to insulin sensitivity in fat, muscle and endometrial tissue biopsies, and biomarkers in whole blood. • Changes in

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026