Food Product for Management of Gestational Diabetes

Not Applicable

Recruiting

• Conditions: Insulin Sensitivity/Resistance; Pregnancy Related; Gestational Diabetes; Glucose Tolerance Impaired; Glucose Tolerance Impaired in Pregnancy

• Registration Number: NCT05917808
• Lead Sponsor: Stoffwechselzentrum Rhein - Pfalz

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-25
• Study Start: 2023-05-29
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-14
• Last Update Submitted: 2023-06-14
• Study First Posted: 2023-06-26
• Last Update Posted: 2023-06-26
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in 2 hour glucose in OGTT	3-7 working days	Change of the 2 hour glucose value in an oral glucose tolerance test

Secondary Outcome Measures

Name	Time	Method
Number of values changing from diabetic to non-diabetic values per patient	3-7 working days	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
Change in plasma insulin 1 hour during OGTT	3-7 working days	Change in plasma insulin 1 hour during OGTT between 1st and second OGTT
Change in plasma insulin 2 hour during OGTT	3-7 working days	Change in plasma insulin 2 hour during OGTT between 1st and second OGTT
Change of the fasting glucose values	3-7 working days	Change in in fasting plasma glucose
Change in 1h glucose in OGTT	3-7 working days	Change of the 1h glucose value in an oral glucose tolerance test from the first to the second OGTT
Number of individuals converting from diabetic to non-diabetic OGTT / fasting glucose	3-7 working days	Number of individuals converting from diabetic to non-diabetic OGTT / fasting glucose according to WHO criteria
Change in homeostasis model assessment (HOMA) Index between 1st and second OGTT	3-7 working days	Change in HOMA Index between 1st and second OGTT
Change in plasma insulin fasting	3-7 working days	Change in plasma insulin fasting between 1st and second OGTT

Trial Locations

Locations (1)

Stoffwechselzentrum Rhein-Pfalz; 🇩🇪 Mannheim, Baden-Württemberg, Germany