Food Product for Management of Gestational Diabetes

Stoffwechselzentrum Rhein - Pfalz25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gestational Diabetes Glucose Tolerance Impaired in Pregnancy Glucose Tolerance Impaired Pregnancy Related

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in 2 hour glucose in OGTT

Change of the 2 hour glucose value in an oral glucose tolerance test

Time frame: 3-7 working days

Secondary Outcomes

Change of the fasting glucose values

Change in in fasting plasma glucose

Time frame: 3-7 working days

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

Time frame: 3-7 working days

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

Time frame: 3-7 working days

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

Time frame: 3-7 working days

Change in plasma insulin fasting

Change in plasma insulin fasting between 1st and second OGTT

Time frame: 3-7 working days

Change in plasma insulin 1 hour during OGTT

Change in plasma insulin 1 hour during OGTT between 1st and second OGTT

Time frame: 3-7 working days

Change in plasma insulin 2 hour during OGTT

Change in plasma insulin 2 hour during OGTT between 1st and second OGTT

Time frame: 3-7 working days

Change in homeostasis model assessment (HOMA) Index between 1st and second OGTT

Change in HOMA Index between 1st and second OGTT

Time frame: 3-7 working days

Food Product for Management of Gestational Diabetes

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts