Food Product for Management of Gestational Diabetes

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Other: Ready-to-eat wholegrain porridge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathological fasting glucose or OGTT according to WHO-criteria for the diagnosis of gestational diabetes (see Table 1). Agree to maintain consistent dietary habits and physical activity levels for the duration of the study. Willingness to complete questionnaires and follow instructions associated with the study and to perform another OGTT at the clinic in a second visit. Has given voluntary, written, informed consent to participate in the study. Exclusion Criteria: Type 2 diabetes prior to pregnancy Psychiatric Disease Acute Infections Alcohol or drug abuse Acute diverticulitis Malignant tumors or hematologic disorders Heart failure stages III-IV according to New York Heart Association (NYHA) Acute coronary syndrome Chronic kidney disease > Stage 3 (Kidney Disease Outcomes Quality Initiative - KDOQI) Celiac disease Diagnosed Inflammatory bowel diseases (mainly Crohn´s, Ulcerative colitis) Allergy to ingredients included in the investigational product. Use of antibiotics within 2 weeks of enrollment Use of probiotics within 2 weeks of enrollment
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: single-center, non-randomized, open, pre-post design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm<br>Only study arm in the study. Participants consume a ready-to-eat wholegrain porridge on two consecutive evenings and repeat OGTT | Other: Ready-to-eat wholegrain porridge<br>* A ready-to-eat wholegrain porridget will be consumed shortly after a diagnostic OGTT on two consecutive evenings, the OGTT will then be repeated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the fasting glucose values | Change in in fasting plasma glucose | 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 | 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 | 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 | 3-7 working days | 
| Change in plasma insulin fasting | Change in plasma insulin fasting between 1st and second OGTT | 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 | 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 | 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 | 3-7 working days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wholegrain, Dietary Intervention, Gestational Diabetes, Impaired Glucose Tolerance, Insulin Sensitivity/Resistance