Diabetes MellitusNCT02114476
Effect of Implantable Contraception on Type-2 DM and Metabolic Syndrome in Women With History of Gestational DM
A study testing progestin implant in people with Diabetes Mellitus and Metabolic Syndrome, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Metabolic Syndrome
- What is being tested?
- progestin implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2014to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Postpartum women with diagnosis of gestational diabetes mellitus
- Want to use implant contraception or nonhormonal contraceptions such as IUD or tubal sterilization
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Metabolic Syndrome
- Being tested
- progestin implant, Placebo
- Keywords
- GDM, implant, diabetes mellitus, metabolic syndrome
- Medical subject headings
- Diabetes Mellitus, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progestin implantDevice
Also called Jadelle
two small (2.5 mm × 43 mm) silicone rods each containing 75 mg of levonorgestrel in a polymer matrix
PlaceboDevice
| Study group | Role | What they receive |
|---|---|---|
| nonhormonal contraception | Placebo comparator | nonhormonal intrauterine device tubal sterilization Receives: Device: Placebo |
| progestin implant | Experimental | Jadelle Receives: Device: progestin implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes mellitus
Incidence of type-2 DM in women with history of gestational diabetes using implantable contraception.
Measured: 5 years
Secondary outcomes (1)
metabolic syndrome
Prevalence of metabolic syndrome in women with history of gestational diabetes using implantable contraception.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2017
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manee Rattanachaiyanont, Mahidol University
- Investigators
- Manee Rattanachaiyanont, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114476
- Sponsor's protocol ID
- GDM-Imp
- Status last verified
- Aug 2018
- First submitted
- 11 Apr 2014
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02114476
- Acronym / sponsor ID
- GDM-Imp
- Conditions
- Diabetes Mellitus, Metabolic Syndrome
- Keywords
- GDM, implant, diabetes mellitus, metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jun 2022 (estimated)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nonhormonal contraception | Placebo comparator | Device: Placebononhormonal intrauterine device tubal sterilization |
| progestin implant | Experimental | Device: progestin implantJadelle |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Postpartum women with diagnosis of gestational diabetes mellitus
- Want to use implant contraception or nonhormonal contraceptions such as IUD or tubal sterilization
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| progestin implantAlso: Jadelletwo small (2.5 mm × 43 mm) silicone rods each containing 75 mg of levonorgestrel in a polymer matrix | Device | progestin implant |
| Placebo | Device | nonhormonal contraception |
Primary outcome
Diabetes mellitus
Time frame: 5 years
Incidence of type-2 DM in women with history of gestational diabetes using implantable contraception.
1 secondary outcome
metabolic syndrome
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manee Rattanachaiyanont, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing progestin implant in people with Diabetes Mellitus and Metabolic Syndrome, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes mellitus (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.