NCT05917808

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

May 29, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

7 months

First QC Date

May 25, 2023

Last Update Submit

June 14, 2023

Conditions

Gestational DiabetesGlucose Tolerance Impaired in PregnancyGlucose Tolerance ImpairedPregnancy RelatedInsulin Sensitivity/Resistance

Keywords

WholegrainDietary InterventionGestational DiabetesImpaired Glucose ToleranceInsulin Sensitivity/Resistance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Change of the fasting glucose values

    3-7 working days

  • Change in 1h glucose in OGTT

    3-7 working days

  • Number of values changing from diabetic to non-diabetic values per patient

    3-7 working days

  • Number of individuals converting from diabetic to non-diabetic OGTT / fasting glucose

    3-7 working days

  • Change in plasma insulin fasting

    3-7 working days

  • +3 more secondary outcomes

Study Arms (1)

Study arm

EXPERIMENTAL

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

Interventions

Ready-to-eat wholegrain porridgeOTHER

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

Study arm

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen with gestational diabetes
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stoffwechselzentrum Rhein-Pfalz

Mannheim, Baden-Wurttemberg, 68163, Germany

RECRUITING

MeSH Terms

Conditions

Diabetes, GestationalGlucose IntoleranceInsulin Resistance

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemiaHyperinsulinism

Central Study Contacts

Azat Samigullin, MD

CONTACT

+49(0)062149096746azat.samigullin@swzrp.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: single-center, non-randomized, open, pre-post design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 26, 2023

Study Start

May 29, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

June 26, 2023

Record last verified: 2023-06

Locations

DE(1)