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Effect of Implantable Contraception on Type-2 DM and Metabolic Syndrome in Women With History of Gestational DM

Primary Purpose

Diabetes Mellitus, Metabolic Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
progestin implant
Placebo
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus focused on measuring GDM, implant, diabetes mellitus, metabolic syndrome

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Postpartum women with diagnosis of gestational diabetes mellitus
  • Want to use implant contraception or nonhormonal contraceptions such as IUD or tubal sterilization

Exclusion Criteria:

  • Age less than 18 years old
  • Diagnosis of diabetes mellitus at post partum period
  • Cardiovascular disease, Liver disease, autoimmune disease
  • The women that reject to continue in the study.

Sites / Locations

  • Faculty of Medicine Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

nonhormonal contraception

progestin implant

Arm Description

nonhormonal intrauterine device tubal sterilization

Jadelle

Outcomes

Primary Outcome Measures

Diabetes mellitus
Incidence of type-2 DM in women with history of gestational diabetes using implantable contraception.

Secondary Outcome Measures

metabolic syndrome
Prevalence of metabolic syndrome in women with history of gestational diabetes using implantable contraception.

Full Information

First Posted
April 11, 2014
Last Updated
August 20, 2018
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT02114476
Brief Title
Effect of Implantable Contraception on Type-2 DM and Metabolic Syndrome in Women With History of Gestational DM
Official Title
Effect of Implantable Progestin-only Contraception on the Incidence of Type 2 Diabetes and Metabolic Syndrome in Thai Women With History of Gestational Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the effect of implantable contraception on the incidence of diabetes mellitus in women with history of gestational diabetes mellitus comparing with those using nonhormonal contraceptives.
Detailed Description
Gestational diabetes mellitus (GDM) was defined as abnormal glucose tolerance detected for the first time in pregnancy. GDM is a well-known risk factor for developing overt diabetes later in life, especially type 2 diabetes. About 50-60% of woman with prior GDM will develop type 2 diabetes during their lifetime. Recent studies show that women with previous GDM exhibit a markedly increased prevalence of the metabolic syndrome, even when glucose tolerance is normal. For both maternal and future offspring, women with prior GDM need safe, efficient, and acceptable choices for contraceptive methods that do not enhance their already substantial risk to develop either overt diabetes or metabolic syndrome and associated sequelae. The intrauterine device (IUD) is a very effective and reversible contraceptive method without metabolic disturbances and therefore is an ideal contraceptive for women with prior GDM. Progestins do not increase globulin production; thus, they do not increase coagulation factors or blood pressure. A nonrandomized open-label prospective trial of healthy obese, reproductive-age women in California were studied about the metabolic effects of progestin-only long-acting reversible contraception levonorgestrel-releasing intrauterine system (LNG-IUS) and etonogestrel implant (ENG-I)] comparing with nonhormonal contraception (NHC). The changes in fasting glucose and insulin sensitivity were seen among obese at 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Metabolic Syndrome
Keywords
GDM, implant, diabetes mellitus, metabolic syndrome

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nonhormonal contraception
Arm Type
Placebo Comparator
Arm Description
nonhormonal intrauterine device tubal sterilization
Arm Title
progestin implant
Arm Type
Experimental
Arm Description
Jadelle
Intervention Type
Device
Intervention Name(s)
progestin implant
Other Intervention Name(s)
Jadelle
Intervention Description
two small (2.5 mm × 43 mm) silicone rods each containing 75 mg of levonorgestrel in a polymer matrix
Intervention Type
Device
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Diabetes mellitus
Description
Incidence of type-2 DM in women with history of gestational diabetes using implantable contraception.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
metabolic syndrome
Description
Prevalence of metabolic syndrome in women with history of gestational diabetes using implantable contraception.
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Postpartum women with diagnosis of gestational diabetes mellitus Want to use implant contraception or nonhormonal contraceptions such as IUD or tubal sterilization Exclusion Criteria: Age less than 18 years old Diagnosis of diabetes mellitus at post partum period Cardiovascular disease, Liver disease, autoimmune disease The women that reject to continue in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manee Rattanachaiyanont, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

Effect of Implantable Contraception on Type-2 DM and Metabolic Syndrome in Women With History of Gestational DM

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