Clinical trial NCT05917808: Food Product for Management of Gestational Diabetes
Official title: A Food Product for Glucose Management in Gestational Diabetes Mellitus - a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes
Glucose Tolerance Impaired in Pregnancy
Glucose Tolerance Impaired
Pregnancy Related
Insulin Sensitivity/Resistance
Keywords: Wholegrain
Dietary Intervention
Gestational Diabetes
Impaired Glucose Tolerance
Insulin Sensitivity/Resistance
Lead sponsor: Stoffwechselzentrum Rhein - Pfalz
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 25
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-center, non-randomized, open, pre-post design
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in 2 hour glucose in OGTT
timeFrame: 3-7 working days
Secondary outcomes:
measure: Change of the fasting glucose values
timeFrame: 3-7 working days
measure: Change in 1h glucose in OGTT
timeFrame: 3-7 working days
measure: Number of values changing from diabetic to non-diabetic values per patient
timeFrame: 3-7 working days
measure: Number of individuals converting from diabetic to non-diabetic OGTT / fasting glucose
timeFrame: 3-7 working days
measure: Change in plasma insulin fasting
timeFrame: 3-7 working days
measure: Change in plasma insulin 1 hour during OGTT
timeFrame: 3-7 working days
measure: Change in plasma insulin 2 hour during OGTT
timeFrame: 3-7 working days
measure: Change in homeostasis model assessment (HOMA) Index between 1st and second OGTT
timeFrame: 3-7 working days
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Stoffwechselzentrum Rhein-Pfalz
state: Baden-Württemberg
Study officials:
References: