Food Product for Management of Gestational Diabetes

Pregnancy Related Clinical Trial

Official title:

A Food Product for Glucose Management in Gestational Diabetes Mellitus - a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05917808
• Other study ID #: GMP2301
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Glucose Intolerance
• Glucose Tolerance Impaired
• Glucose Tolerance Impaired in Pregnancy
• Hypersensitivity
• Insulin Resistance
• Insulin Sensitivity/Resistance
• Pregnancy Related

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