Food Product for Management of Gestational Diabetes

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related; Insulin Sensitivity/Resistance; Gestational Diabetes; Glucose Tolerance Impaired; Glucose Tolerance Impaired in Pregnancy
• Intervention / Treatment: Other: Ready-to-eat wholegrain porridge

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Azat Samigullin, MD; Phone Number: +49(0)062149096746; Email: azat.samigullin@swzrp.de

Study Locations

• Germany
  • Baden-Württemberg
    • Mannheim, Baden-Württemberg, Germany, 68163
      • Recruiting
      • Stoffwechselzentrum Rhein-Pfalz
      • Contact: Azat Samigullin, MD; Email: azat.samigullin@swzrp.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stoffwechselzentrum Rhein - Pfalz

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Dietary Intervention; Gestational Diabetes; Impaired Glucose Tolerance; Wholegrain; Insulin Sensitivity/Resistance
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Endocrine System Diseases; Hyperinsulinism; Pregnancy Complications; Hyperglycemia; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypersensitivity; Diabetes Mellitus; Glucose Intolerance; Insulin Resistance; Diabetes, Gestational
• Other Study ID Numbers: GMP2301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No