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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05917808
Other study ID # GMP2301
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 29, 2023
Est. completion date December 31, 2023

Study information

Verified date June 2023
Source Stoffwechselzentrum Rhein - Pfalz
Contact Azat Samigullin, MD
Phone +49(0)062149096746
Email azat.samigullin@swzrp.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 information / eligibility

Status Recruiting
Enrollment 25
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Germany Stoffwechselzentrum Rhein-Pfalz Mannheim Baden-Württemberg

Sponsors (1)

Lead Sponsor Collaborator
Stoffwechselzentrum Rhein - Pfalz

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in 2 hour glucose in OGTT Change of the 2 hour glucose value in an oral glucose tolerance test 3-7 working days
Secondary Change of the fasting glucose values Change in in fasting plasma glucose 3-7 working days
Secondary Change in 1h glucose in OGTT Change of the 1h glucose value in an oral glucose tolerance test from the first to the second OGTT 3-7 working days
Secondary Number of values changing from diabetic to non-diabetic values per patient Number of values changing from above the diabetic threshold to below diabetic threshold per patient in the cohort according to World Health Organization (WHO) definitions 3-7 working days
Secondary Number of individuals converting from diabetic to non-diabetic OGTT / fasting glucose Number of individuals converting from diabetic to non-diabetic OGTT / fasting glucose according to WHO criteria 3-7 working days
Secondary Change in plasma insulin fasting Change in plasma insulin fasting between 1st and second OGTT 3-7 working days
Secondary Change in plasma insulin 1 hour during OGTT Change in plasma insulin 1 hour during OGTT between 1st and second OGTT 3-7 working days
Secondary Change in plasma insulin 2 hour during OGTT Change in plasma insulin 2 hour during OGTT between 1st and second OGTT 3-7 working days
Secondary Change in homeostasis model assessment (HOMA) Index between 1st and second OGTT Change in HOMA Index between 1st and second OGTT 3-7 working days
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