Gestational Diabetes, Glucose Tolerance Impaired, Glucose Tolerance Impaired in Pregnancy, Insulin Sensitivity/Resistance, Pregnancy Related
Conditions
Keywords
Wholegrain, Dietary Intervention, Gestational Diabetes, Impaired Glucose Tolerance, Insulin Sensitivity/Resistance
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.
Interventions
OTHERReady-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
Sponsors
Stoffwechselzentrum Rhein - Pfalz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single-center, non-randomized, open, pre-post design
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 plasma insulin fasting | 3-7 working days | Change in plasma insulin fasting between 1st and second OGTT |
| 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 in homeostasis model assessment (HOMA) Index between 1st and second OGTT | 3-7 working days | Change in HOMA Index between 1st and second OGTT |
Countries
Germany
Contacts
Primary ContactAzat Samigullin, MD
Outcome results
None listed