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

August 20, 2018 updated by: Manee Rattanachaiyanont, Mahidol University

Effect of Implantable Progestin-only Contraception on the Incidence of Type 2 Diabetes and Metabolic Syndrome in Thai Women With History of Gestational Diabetes

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: nonhormonal contraception
nonhormonal intrauterine device tubal sterilization
Device: Placebo
Experimental: progestin implant
Jadelle
Device: progestin implant
two small (2.5 mm × 43 mm) silicone rods each containing 75 mg of levonorgestrel in a polymer matrix
Other Names:
  • Jadelle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes mellitus
Time Frame: 5 years
Incidence of type-2 DM in women with history of gestational diabetes using implantable contraception.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
metabolic syndrome
Time Frame: 5 years
Prevalence of metabolic syndrome in women with history of gestational diabetes using implantable contraception.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Manee Rattanachaiyanont, MD, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

March 1, 2017

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

April 11, 2014

First Submitted That Met QC Criteria

April 14, 2014

First Posted (Estimate)

April 15, 2014

Study Record Updates

Last Update Posted (Actual)

August 22, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GDM-Imp

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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