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Research of Intensive Lifestyle Intervention for PCOS Patients With IGT

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ClinicalTrials.gov Identifier: NCT02446834
Recruitment Status : Unknown
Verified October 2016 by RenJi Hospital.
Recruitment status was:  Recruiting
First Posted : May 18, 2015
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Behavioral: intensive lifestyle intervention Drug: GLP-1 Receptor Agonists Drug: Metformin Drug: Acarbose Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Treatment
Official Title: Research of Intensive Lifestyle Intervention for Overweight PCOS Patients With Impaired Glucose Tolerance in Their Metabolic and Reproductive Abnormalities Treatment
Study Start Date : April 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Acarbose

Arm Intervention/treatment
Experimental: intensive lifestyle intervention
3 months intensive lifestyle intervention, including low GI diet and exercise.
Behavioral: intensive lifestyle intervention
3 months low GI diet and exercise
Other Name: group 1

Experimental: GLP-1 Receptor Agonists
3 months GLP-1 Receptor Agonists treatment
Drug: GLP-1 Receptor Agonists
Use GLP-1 Receptor Agonists 3 months to treat PCOS
Other Name: group 2

Experimental: metformin
3 months metformin treatment
Drug: Metformin
Use metformin 3 months to treat PCOS
Other Name: group 3

Experimental: acarbose
3 months acarbose treatment
Drug: Acarbose
Use acarbose 3 months to treat PCOS
Other Name: group 4




Primary Outcome Measures :
  1. changes of Islet β-cell functions from baseline [ Time Frame: up to 12 weeks ]
    Insulin and blood glucose levels


Secondary Outcome Measures :
  1. Incretin [ Time Frame: up to 12 weeks ]
    GLP-1, glucagon,GIP, PYY

  2. Intra-abdominal fat distribution [ Time Frame: up to 12 weeks ]
  3. Sex Hormone [ Time Frame: up to 12 weeks ]
  4. Menstrual Cycle [ Time Frame: up to 12 weeks ]


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Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02446834


Contacts
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Contact: Tao Tao, MD +86-13817701776 taotaozhen@hotmail.com
Contact: Wendi Xu, MD +86-13564671899 cindy_525@me.com

Locations
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China, Shanghai
Renji Hospital Department of Endocrinology and Metabolism Recruiting
Shanghai, Shanghai, China, 200127
Contact: Wei Liu, MD    +86-18918358342    sue_liuwei@163.com   
Contact: Jing Ma, MD    +86-15800983436    cherry1996@live.cn   
Sponsors and Collaborators
RenJi Hospital
Investigators
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Study Chair: Tao Tao, MD RenJi Hospital Department of Endocrinology and Metabolism

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT02446834     History of Changes
Other Study ID Numbers: [2015]018K
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by RenJi Hospital:
PCOS
intensive lifestyle intervention
IGT
drugs treatment
Additional relevant MeSH terms:
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Ovarian Cysts
Ovarian Diseases
Glucagon-Like Peptide 1
Polycystic Ovary Syndrome
Cysts
Neoplasms
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Acarbose
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action