NCT02446834

Brief Summary

Compare the efficacy between intensive lifestyle intervention and drugs (GLP-1 Receptor Agonists, metformin and acarbose) for PCOS patients with early onset diabetes in their metabolic and reproductive abnormalities treatment; clear the treatment effect and mechanism of intensive lifestyle intervention to PCOS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

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

April 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 6, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 18, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

October 17, 2022

Status Verified

November 1, 2017

Enrollment Period

2.7 years

First QC Date

May 6, 2015

Last Update Submit

October 13, 2022

Conditions

Polycystic Ovary Syndrome

Keywords

PCOSintensive lifestyle interventionIGTdrugs treatment

Outcome Measures

Primary Outcomes (1)

  • changes of Islet β-cell functions from baseline

    Insulin and blood glucose levels

    up to 12 weeks

Secondary Outcomes (3)

  • Incretin

    up to 12 weeks

  • Intra-abdominal fat distribution

    up to 12 weeks

  • Sex Hormone

    up to 12 weeks

Study Arms (4)

intensive lifestyle intervention

EXPERIMENTAL

3 months intensive lifestyle intervention, including low GI diet and exercise.

Behavioral: intensive lifestyle intervention

GLP-1 Receptor Agonists

EXPERIMENTAL

3 months GLP-1 Receptor Agonists treatment

Drug: GLP-1 Receptor Agonists

metformin

EXPERIMENTAL

3 months metformin treatment

Drug: Metformin

acarbose

EXPERIMENTAL

3 months acarbose treatment

Drug: Acarbose

Interventions

intensive lifestyle interventionBEHAVIORAL

3 months low GI diet and exercise

Also known as: group 1
intensive lifestyle intervention
GLP-1 Receptor AgonistsDRUG

Use GLP-1 Receptor Agonists 3 months to treat PCOS

Also known as: group 2
GLP-1 Receptor Agonists
MetforminDRUG

Use metformin 3 months to treat PCOS

Also known as: group 3
metformin
AcarboseDRUG

Use acarbose 3 months to treat PCOS

Also known as: group 4
acarbose

Eligibility Criteria

Age14 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Overweight and obese PCOS patients with newly diagnosed IGT; PCOS diagnosis based on 1990 NIH criteria. Overweight / obesity diagnostic criteria according to WHO-WPR. IGT diagnostic criteria according to 1998 WHO diagnostic criteria.

You may not qualify if:

  • Except for serious complications (cardiovascular events and recent significant kidney or lung disease within 3 months), and had high blood pressure (\>160/100mmHg), blood sugar and high blood lipids (glycated hemoglobin\> 11%, triglycerides \>600 mg/dl).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital Department of Endocrinology and Metabolism

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Glucagon-Like Peptide-1 Receptor AgonistsMetforminAcarbose

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Hypoglycemic AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesBiguanidesGuanidinesAmidinesOrganic ChemicalsTrisaccharidesOligosaccharidesPolysaccharidesCarbohydrates

Study Officials

  • Tao Tao, MD

    RenJi Hospital Department of Endocrinology and Metabolism

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Open Label
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2015

First Posted

May 18, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2017

Study Completion

April 1, 2018

Last Updated

October 17, 2022

Record last verified: 2017-11

Locations

CN(1)