Gestational Diabetes MellitusGESDICANCT02436551
Gestational Diabetes in Central Asia: Prevalence and Management
An observational study of Gestational Diabetes Mellitus, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
Evaluate prevalence and management of gestational diabetes in Tajikistan in two different settings (one rural and one urban). Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Observation
- How many people
- 3,200 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2015to Jul 2018
- Phase
- Observational
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant women in rural setting; pregnant women in urban setting;
Who may be able to join
- pregnancy
Who cannot join
- known diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Evaluate prevalence and management of gestational diabetes in Tajikistan in two different settings (one rural and one urban).
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Observation
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women in Tajikistan | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of gestational diabetes
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, Helmholtz Zentrum München
- Responsible party
- Principal investigator, Klaus Parhofer, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436551
- Sponsor's protocol ID
- GESDICA
- Acronym
- GESDICA
- Status last verified
- Feb 2019
- First submitted
- 4 May 2015
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gestational Diabetes in Central Asia: Prevalence and Management
- ClinicalTrials.gov ID
- NCT02436551
- Acronym / sponsor ID
- GESDICA / GESDICA
- Conditions
- Gestational Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,200 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, Helmholtz Zentrum München
- Study start
- Sep 2015
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 7 May 2015 (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.
Evaluate prevalence and management of gestational diabetes in Tajikistan in two different settings (one rural and one urban).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women in Tajikistan | – | Other: Observation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant women in rural setting; pregnant women in urban setting;
Key inclusion criteria (1 listed)
- pregnancy
Key exclusion criteria (1 listed)
- known diabetes mellitus
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 |
|---|---|---|
| Observation | Other | Pregnant women in Tajikistan |
Primary outcome
prevalence of gestational diabetes
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes Mellitus, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Feb 2019. 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 Germany. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
prevalence of gestational diabetes (time frame: 1 year). 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 27 Feb 2019.