| NCT ID | NCT04270578 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Tuebingen |
| Condition | Gestational Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2012-05-23 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2012-05-23 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Due to a changed lifestyle with less physical activity, unfavorable diets rich in fat and calories and obesity, the prevalence of diabetes mellitus is increasing worldwide. The diabetes epidemic is associated with significant personal and socio-economic consequences. Despite attempts to prevent the complications of diabetes, this disease is still the leading cause of blindness, chronic renal insufficiency and non-traumatic amputation. It is important to detect early on an increase in blood sugar and treat it accordingly to reduce costs and to minimize the personal suffering of those affected. As the number of patients with type 2 diabetes mellitus continues to rise, the number of young women with gestational diabetes mellitus (GDM) also increases. This is a disorder og glucose metabolism, which occurs for the first time in pregnancy. The causes for this are manifold. Among other causes, the increasing age of the mothers and weight gain during pregnancy are risk factors for gestational diabetes. Although it has been recommended that women with gestational diabetes should be re-examined after the birth of their child, many women have not. The study is a follow-up study to clarify whether insulin secretion disorder in women with and after GDM is a risk factor for the occurrence of type 2 diabetes mellitus.
Eligibility Criteria
Inclusion Criteria: \- Signed and dated informed consent Enrollment is possible during AND after gestation: * Baseline visit (pregnancy): gestational week 24+0 till 31+6 * Postpartum visits: documented occurence of GDM in previous pregnancy Exclusion Criteria: * Age \< 18years * Diabetes Mellitus Type 1 or Type 2 * GFR \< 60 ml/min/1,73 m2 * CRP \> 1 mg/dl * Increased levels of transaminases 2 fold above ULN * Preexisting cardiac conditions * Weight loss \> 10% within 6 months prior to inclusion * Psychiatric disorders * Chronic alcohol or substance abuse * Blood sugar increasing or decreasing drug therapy, e.g. steroids, antidiabetics, insulin * only postpartum visits: pregnancy or lactation
Contact & Investigator
Andreas Fritsche, MD
PRINCIPAL INVESTIGATOR
University Hospital Tuebingen
Frequently Asked Questions
Who can join the NCT04270578 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Gestational Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04270578 currently recruiting?
Yes, NCT04270578 is actively recruiting participants. Contact the research team at andreas.fritsche@med.uni-tuebingen.de for enrollment information.
Where is the NCT04270578 trial being conducted?
This trial is being conducted at Tübingen, Germany.
Who is sponsoring the NCT04270578 clinical trial?
NCT04270578 is sponsored by University Hospital Tuebingen. The principal investigator is Andreas Fritsche, MD at University Hospital Tuebingen. The trial plans to enroll 800 participants.
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