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Polycystic Ovary SyndromeNCT02446834

Research of Intensive Lifestyle Intervention for PCOS Patients With IGT

A study testing intensive lifestyle intervention, GLP-1 Receptor Agonists and Metformin in people with Polycystic Ovary Syndrome, run by RenJi Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 50 years, women only
Conditions the study is for
Polycystic Ovary Syndrome
What is being tested?
intensive lifestyle intervention, GLP-1 Receptor Agonists and Metformin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
Apr 2015to Apr 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 50 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Renji Hospital Department of Endocrinology and Metabolism

    Shanghai, Shanghai Municipality, 200127

Other trials in China

About this study

Official title: Research of Intensive Lifestyle Intervention for Overweight PCOS Patients With Impaired Glucose Tolerance in Their Metabolic and Reproductive Abnormalities Treatment

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.

Read the detailed description

We designed a non randomized control study to 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 We planed to enroll 48 patients.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. 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).

Then we devided the 48 patients into 4 groups: intensive lifestyle intervention group, GLP-1 group, metformin group and acarbose group, and each group 12 samples. Each group use specific treatment(showed as the group name) 3 months. Before and after the intervention, the blood samples would be collected to Glucose, Insulin, GLP-1, Glucagon, sex hormones, Blood chemistry for liver and kidney function ect, as well as the image examinations.

We will compare the data of each patient, finally identify the treatment effect and mechanism of intensive lifestyle intervention to PCOS.

Being tested
intensive lifestyle intervention, GLP-1 Receptor Agonists, Metformin, Acarbose
Keywords
PCOS, intensive lifestyle intervention, IGT, drugs treatment
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intensive lifestyle interventionBehavioural

    Also called group 1

    3 months low GI diet and exercise

  • GLP-1 Receptor AgonistsDrug

    Also called group 2

    Use GLP-1 Receptor Agonists 3 months to treat PCOS

  • MetforminDrug

    Also called group 3

    Use metformin 3 months to treat PCOS

  • AcarboseDrug

    Also called group 4

    Use acarbose 3 months to treat PCOS

Study groups in NCT02446834
Study groupRoleWhat they receive
intensive lifestyle interventionExperimental3 months intensive lifestyle intervention, including low GI diet and exercise.
Receives: Behavioral: intensive lifestyle intervention
GLP-1 Receptor AgonistsExperimental3 months GLP-1 Receptor Agonists treatment
Receives: Drug: GLP-1 Receptor Agonists
metforminExperimental3 months metformin treatment
Receives: Drug: Metformin
acarboseExperimental3 months acarbose treatment
Receives: Drug: Acarbose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. changes of Islet β-cell functions from baseline

    Insulin and blood glucose levels

    Measured: up to 12 weeks

Secondary outcomes (3)

  1. Incretin

    GLP-1, glucagon，GIP, PYY

    Measured: up to 12 weeks

  2. Intra-abdominal fat distribution

    measured by MRI

    Measured: up to 12 weeks

  3. Sex Hormone

    testosterone, estradiol, LH, and FSH

    Measured: up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionDec 2017
  4. Study completionApr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02446834
Sponsor's protocol ID
[2015]018K
Status last verified
Nov 2017
First submitted
6 May 2015
Last updated
17 Oct 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing intensive lifestyle intervention, GLP-1 Receptor Agonists and Metformin in people with Polycystic Ovary Syndrome, run by RenJi Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

changes of Islet β-cell functions from baseline (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02446834.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.

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