Wholegrain product for managing gestational diabetes
A Food Product for Glucose Management in Gestational Diabetes Mellitus - a Pilot Study
This study is testing if eating a ready-to-eat wholegrain porridge can help women with gestational diabetes manage their blood sugar better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Sex | Female |
| Sponsor | Stoffwechselzentrum Rhein - Pfalz Academic / other |
| Locations | 1 site (Mannheim, Baden-Württemberg) |
| Trial ID | NCT05917808 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial aims to evaluate the effects of a ready-to-eat wholegrain porridge on glucose tolerance and insulin sensitivity in patients newly diagnosed with gestational diabetes. Participants will consume the product on two consecutive evenings after an initial oral glucose tolerance test (OGTT) and will undergo a second OGTT to assess any improvements. The study will compare the results of the two tests to determine the efficacy of the wholegrain intervention.
Who should consider this trial
Good fit: Ideal candidates are pregnant women diagnosed with gestational diabetes who meet specific inclusion criteria.
Not a fit: Patients with pre-existing type 2 diabetes or certain acute and chronic health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could help improve glucose management in pregnant women with gestational diabetes.
How similar studies have performed: While this approach is novel, similar dietary interventions have shown promise in managing glucose levels in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Pathological fasting glucose or OGTT according to WHO-criteria for the diagnosis of gestational diabetes (see Table 1). 2. Agree to maintain consistent dietary habits and physical activity levels for the duration of the study. 3. Willingness to complete questionnaires and follow instructions associated with the study and to perform another OGTT at the clinic in a second visit. 4. Has given voluntary, written, informed consent to participate in the study. Exclusion Criteria: 1. Type 2 diabetes prior to pregnancy 2. Psychiatric Disease 3. Acute Infections 4. Alcohol or drug abuse 5. Acute diverticulitis 6. Malignant tumors or hematologic disorders 7. Heart failure stages III-IV according to New York Heart Association (NYHA) 8. Acute coronary syndrome 9. Chronic kidney disease \> Stage 3 (Kidney Disease Outcomes Quality Initiative - KDOQI) 10. Celiac disease 11. Diagnosed Inflammatory bowel diseases (mainly Crohn´s, Ulcerative colitis) 12. Allergy to ingredients included in the investigational product. 13. Use of antibiotics within 2 weeks of enrollment 14. Use of probiotics within 2 weeks of enrollment
Where this trial is running
Mannheim, Baden-Württemberg
- Stoffwechselzentrum Rhein-Pfalz — Mannheim, Baden-Württemberg, Germany (Recruiting)
Study contacts
- Study coordinator: Azat Samigullin, MD
- Email: azat.samigullin@swzrp.de
- Phone: +49(0)062149096746
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.