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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02114476
• Other study ID #: GDM-Imp
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2014
• Est. completion date: June 2022

Study information

• Verified date: August 2018
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 260
• Est. completion date: June 2022
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Device:
• progestin implant
two small (2.5 mm × 43 mm) silicone rods each containing 75 mg of levonorgestrel in a polymer matrix
• Placebo

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes mellitus	Incidence of type-2 DM in women with history of gestational diabetes using implantable contraception.	5 years
Secondary	metabolic syndrome	Prevalence of metabolic syndrome in women with history of gestational diabetes using implantable contraception.	5 years