Food Product for Management of Gestational Diabetes

NCT ID: NCT05917808

Last Updated: 2023-06-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-29
• Study Completion Date: 2023-12-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study arm

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

Group Type: EXPERIMENTAL

Ready-to-eat wholegrain porridge

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Stoffwechselzentrum Rhein - Pfalz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stoffwechselzentrum Rhein-Pfalz

Mannheim, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Azat Samigullin, MD

Role: CONTACT

azat.samigullin@swzrp.de

+49(0)062149096746

Facility Contacts

Azat Samigullin, MD

Role: primary

azat.samigullin@swzrp.de

Other Identifiers

GMP2301

Identifier Type: -

Identifier Source: org_study_id