Clinical trial NCT02114476: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Metabolic Syndrome
Keywords: GDM
implant
diabetes mellitus
metabolic syndrome
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 260
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Diabetes mellitus
timeFrame: 5 years
Secondary outcomes:
measure: metabolic syndrome
timeFrame: 5 years
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Manee Rattanachaiyanont, MD
role: PRINCIPAL_INVESTIGATOR
References: