Clinical Trials

Food Product for Management of Gestational Diabetes

Study Purpose

The goal of this pilot open pre-post clinical trial is to test effects of a wholegrain product in patients with newly diagnosed gestational diabetes. The main question it aims to answer is: Does the wholegrain product improve glucose tolerance and insulin sensitivity during a 75 g oral glucose tolerance test (OGTT). Participants will consume product on two consecutive evenings shortly after the first OGTT and will then perform a second OGTT. Researchers will compare the results of the first and second OGTT to see if glucose tolerance improved after consumption of the test product.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A and Over
Gender	Female

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05917808
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Stoffwechselzentrum Rhein - Pfalz
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Gestational Diabetes, Glucose Tolerance Impaired in Pregnancy, Glucose Tolerance Impaired, Pregnancy Related, Insulin Sensitivity/Resistance

Arms & Interventions

Arms

Experimental: Study arm

Only study arm in the study. Participants consume a ready-to-eat wholegrain porridge on two consecutive evenings and repeat OGTT

Interventions

Other: - Ready-to-eat wholegrain porridge

A ready-to-eat wholegrain porridget will be consumed shortly after a diagnostic OGTT on two consecutive evenings, the OGTT will then be repeated

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Stoffwechselzentrum Rhein-Pfalz, Mannheim, Baden-Württemberg, Germany

Status

Recruiting

Address

Stoffwechselzentrum Rhein-Pfalz

Mannheim, Baden-Württemberg, 68163

Site Contact

Azat Samigullin, MD

[email protected]

+49(0)062149096746

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