Food Product for Management of Gestational Diabetes | NCT05917808

Studies
Food Product for Management of Gestational Diabetes

NCT05917808

Sponsor

Stoffwechselzentrum Rhein - Pfalz

Status

Unknown status

Last Update Posted

Jun 26, 2023Actual

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Gestational Diabetes
Glucose Tolerance Impaired in Pregnancy
Glucose Tolerance Impaired
Pregnancy Related
Insulin Sensitivity/Resistance

Interventions

Ready-to-eat wholegrain porridge

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 29, 2023Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

May 25, 2023

First Submission Date that Met QC Criteria

Jun 14, 2023

First Posted Date

Jun 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2023

Last Update Posted Date

Jun 26, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ready-to-eat wholegrain porridge	Other	A ready-to-eat wholegrain porridget will be consumed shortly after a diagnostic OGTT on two consecutive evenings, the OGTT will then be repeated

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

women with gestational diabetes

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Azat Samigullin, MD	Contact	+49(0)062149096746		azat.samigullin@swzrp.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stoffwechselzentrum Rhein-Pfalz	Recruiting	Mannheim	Baden-Wurttemberg	68163	Germany

Condition Browse Module

MeSH Terms

ID	Term
D016640	Diabetes, Gestational
D018149	Glucose Intolerance
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D003920	Diabetes Mellitus

Browse Leaves

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Browse Branches

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