NCT01457209

Brief Summary

The central hypothesis is that acupuncture break the vicious circle of androgen excess and reverse insulin resistance and improve health related quality of life and affective symptoms in overweight and obese women with and without Polycystic Ovary Syndrome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 21, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

2.2 years

First QC Date

October 6, 2011

Last Update Submit

January 20, 2014

Conditions

Polycystic Ovary SyndromeInsulin Resistance

Keywords

PCOSInsulin resistanceAcupuncture

Outcome Measures

Primary Outcomes (1)

  • Change in insulin sensitivity

    glucose disposal rate measured by euglycemic hyperinsulinemic clamp.

    Day 1 and Week 5

Secondary Outcomes (4)

  • Change in insulin signaling (muscle and adipose tissue)

    Day 1 and Week 5

  • Change in health related quality of life

    Day 1 and Week 5

  • Change in symptoms of anxiety and depression

    Day 1 and Week 5

  • Change in circulating sex steroids, adipokines, lipids and inflammatory markers

    Day 1 and Week 5

Interventions

AcupunctureOTHER

Needle placement in abdominal muscles, in m. vastus lateralis, lower leg and hands. Stimulation: Manual rotation of the needles and electrical stimulation of the needles in the abdominal muscles and m. vastus lateralis will be stimulated electrically with low burst frequency Duration: 30 min Treatment: 3 times/wk during 5 weeks.

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \> 25 to \< 35 and
  • Clinical signs of hyperandrogenism (hirsutism or acne) and
  • At least one of the following two signs; oligo/amenorrhea and/or ultrasound-verified polycystic ovaries
  • Controls should have BMI \> 25 to \< 35, regular cycles with 28 days ± 2 days, no signs of hyperandrogenism.

You may not qualify if:

  • Age \> 38 years
  • Autoimmune disorders, cancer, Type I diabetes and Type 2 diabetes.
  • Pharmacological treatment (cortisone, antidepressant, antidiabetic, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 wks accounts for all participants.
  • Blood pressure \>160 / 100 mmHg
  • Pregnancy or breastfeeding the last 6 months
  • Acupuncture last 2 months
  • Language barrier or disabled person with reduced ability to understand information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Neuroscienncec and Physiology

Gothenburg, 43252, Sweden

Location

Related Publications (3)

  • Benrick A, Pillon NJ, Nilsson E, Lindgren E, Krook A, Ling C, Stener-Victorin E. Electroacupuncture Mimics Exercise-Induced Changes in Skeletal Muscle Gene Expression in Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2020 Jun 1;105(6):2027-41. doi: 10.1210/clinem/dgaa165.

    PMID: 32232327DERIVED

  • Nilsson E, Benrick A, Kokosar M, Krook A, Lindgren E, Kallman T, Martis MM, Hojlund K, Ling C, Stener-Victorin E. Transcriptional and Epigenetic Changes Influencing Skeletal Muscle Metabolism in Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2018 Dec 1;103(12):4465-4477. doi: 10.1210/jc.2018-00935.

    PMID: 30113663DERIVED

  • Zheng Y, Stener-Victorin E, Ng EH, Li J, Wu X, Ma H. How does acupuncture affect insulin sensitivity in women with polycystic ovary syndrome and insulin resistance? Study protocol of a prospective pilot study. BMJ Open. 2015 May 3;5(4):e007757. doi: 10.1136/bmjopen-2015-007757.

    PMID: 25941189DERIVED

MeSH Terms

Conditions

Polycystic Ovary SyndromeInsulin Resistance

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2011

First Posted

October 21, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

SE(1)