Food Product for Management of Gestational Diabetes

Sponsor

Stoffwechselzentrum Rhein - Pfalz (Other)

Overall Status

Recruiting

CT.gov ID

NCT05917808

Collaborator

(none)

Enrollment

Location

Arm

7.1

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gestational Diabetes Glucose Tolerance Impaired in Pregnancy Glucose Tolerance Impaired Pregnancy Related Insulin Sensitivity/Resistance	Other: Ready-to-eat wholegrain porridge	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

single-center, non-randomized, open, pre-post designsingle-center, non-randomized, open, pre-post design

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 29, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study arm 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 A ready-to-eat wholegrain porridget will be consumed shortly after a diagnostic OGTT on two consecutive evenings, the OGTT will then be repeated

Arm

Intervention/Treatment

Experimental: Study arm

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

A ready-to-eat wholegrain porridget will be consumed shortly after a diagnostic OGTT on two consecutive evenings, the OGTT will then be repeated

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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