search
Back to results

Food Product for Management of Gestational Diabetes

Primary Purpose

Gestational Diabetes, Glucose Tolerance Impaired in Pregnancy, Glucose Tolerance Impaired

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Ready-to-eat wholegrain porridge
Sponsored by
Stoffwechselzentrum Rhein - Pfalz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes focused on measuring Wholegrain, Dietary Intervention, Gestational Diabetes, Impaired Glucose Tolerance, Insulin Sensitivity/Resistance

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Stoffwechselzentrum Rhein-PfalzRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study arm

Arm Description

Only study arm in the study. Participants consume a ready-to-eat wholegrain porridge on two consecutive evenings and repeat OGTT

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change of the fasting glucose values
Change in in fasting plasma glucose
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
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
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
Change in plasma insulin fasting
Change in plasma insulin fasting between 1st and second OGTT
Change in plasma insulin 1 hour during OGTT
Change in plasma insulin 1 hour during OGTT between 1st and second OGTT
Change in plasma insulin 2 hour during OGTT
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
Change in HOMA Index between 1st and second OGTT

Full Information

First Posted
May 25, 2023
Last Updated
June 14, 2023
Sponsor
Stoffwechselzentrum Rhein - Pfalz
search

1. Study Identification

Unique Protocol Identification Number
NCT05917808
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 29, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stoffwechselzentrum Rhein - Pfalz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
single-center, non-randomized, open, pre-post design
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study arm
Arm Type
Experimental
Arm Description
Only study arm in the study. Participants consume a ready-to-eat wholegrain porridge on two consecutive evenings and repeat OGTT
Intervention Type
Other
Intervention Name(s)
Ready-to-eat wholegrain porridge
Intervention Description
A ready-to-eat wholegrain porridget will be consumed shortly after a diagnostic OGTT on two consecutive evenings, the OGTT will then be repeated
Primary Outcome Measure Information:
Title
Change in 2 hour glucose in OGTT
Description
Change of the 2 hour glucose value in an oral glucose tolerance test
Time Frame
3-7 working days
Secondary Outcome Measure Information:
Title
Change of the fasting glucose values
Description
Change in in fasting plasma glucose
Time Frame
3-7 working days
Title
Change in 1h glucose in OGTT
Description
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
Title
Number of values changing from diabetic to non-diabetic values per patient
Description
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
Title
Number of individuals converting from diabetic to non-diabetic OGTT / fasting glucose
Description
Number of individuals converting from diabetic to non-diabetic OGTT / fasting glucose according to WHO criteria
Time Frame
3-7 working days
Title
Change in plasma insulin fasting
Description
Change in plasma insulin fasting between 1st and second OGTT
Time Frame
3-7 working days
Title
Change in plasma insulin 1 hour during OGTT
Description
Change in plasma insulin 1 hour during OGTT between 1st and second OGTT
Time Frame
3-7 working days
Title
Change in plasma insulin 2 hour during OGTT
Description
Change in plasma insulin 2 hour during OGTT between 1st and second OGTT
Time Frame
3-7 working days
Title
Change in homeostasis model assessment (HOMA) Index between 1st and second OGTT
Description
Change in HOMA Index between 1st and second OGTT
Time Frame
3-7 working days

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
women with gestational diabetes
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Azat Samigullin, MD
Phone
+49(0)062149096746
Email
azat.samigullin@swzrp.de
Facility Information:
Facility Name
Stoffwechselzentrum Rhein-Pfalz
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68163
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Azat Samigullin, MD
Email
azat.samigullin@swzrp.de

12. IPD Sharing Statement

Learn more about this trial

Food Product for Management of Gestational Diabetes

We'll reach out to this number within 24 hrs