Food Product for Management of Gestational Diabetes

Stoffwechselzentrum Rhein - Pfalz

Status: Enrolling

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

Treatments: Other: Ready-to-eat wholegrain porridge

Study type: Interventional

Funder types: Other

Identifiers

NCT05917808

GMP2301

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Study arm

Experimental group

Description:

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

Treatment:

Other: Ready-to-eat wholegrain porridge