Gestational DiabetesNCT05917808
Food Product for Management of Gestational Diabetes
A study testing Ready-to-eat wholegrain porridge in people with Gestational Diabetes and Glucose Tolerance Impaired in Pregnancy, run by Stoffwechselzentrum Rhein - Pfalz at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Glucose Tolerance Impaired in Pregnancy, Glucose Tolerance Impaired
- What is being tested?
- Ready-to-eat wholegrain porridge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 29 May 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Type 2 diabetes prior to pregnancy
- Psychiatric Disease
- Acute Infections
- Alcohol or drug abuse
- Acute diverticulitis
- Malignant tumors or hematologic disorders
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Stoffwechselzentrum Rhein-Pfalz
Mannheim, Baden-Wurttemberg, 68163
Azat Samigullin, MD, azat.samigullin@swzrp.de
About this study
Official title: 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.
- Conditions
- Gestational Diabetes, Glucose Tolerance Impaired in Pregnancy, Glucose Tolerance Impaired, Pregnancy Related, Insulin Sensitivity/Resistance
- Being tested
- Ready-to-eat wholegrain porridge
- Keywords
- Wholegrain, Dietary Intervention, Gestational Diabetes, Impaired Glucose Tolerance, Insulin Sensitivity/Resistance
- Medical subject headings
- Diabetes, Gestational, Glucose Intolerance, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Only study arm in the study. Participants consume a ready-to-eat wholegrain porridge on two consecutive evenings and repeat OGTT Receives: Other: Ready-to-eat wholegrain porridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 2 hour glucose in OGTT
Change of the 2 hour glucose value in an oral glucose tolerance test
Measured: 3-7 working days
Secondary outcomes (8)
Change of the fasting glucose values
Change in in fasting plasma glucose
Measured: 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
Measured: 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
Measured: 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
Measured: 3-7 working days
Change in plasma insulin fasting
Change in plasma insulin fasting between 1st and second OGTT
Measured: 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
Measured: 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
Measured: 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
Measured: 3-7 working days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start29 May 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-center, non-randomized, open, pre-post design
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stoffwechselzentrum Rhein - Pfalz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917808
- Sponsor's protocol ID
- GMP2301
- Status last verified
- Jun 2023
- First submitted
- 25 May 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Food Product for Glucose Management in Gestational Diabetes Mellitus - a Pilot Study
- ClinicalTrials.gov ID
- NCT05917808
- Acronym / sponsor ID
- GMP2301
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Stoffwechselzentrum Rhein - PfalzUniversity, hospital or other
- Study start
- 29 May 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-center, non-randomized, open, pre-post design
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Other: Ready-to-eat wholegrain porridgeOnly study arm in the study. Participants consume a ready-to-eat wholegrain porridge on two consecutive evenings and repeat OGTT |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- Type 2 diabetes prior to pregnancy
- Psychiatric Disease
- Acute Infections
- Alcohol or drug abuse
- Acute diverticulitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ready-to-eat wholegrain porridgeA ready-to-eat wholegrain porridget will be consumed shortly after a diagnostic OGTT on two consecutive evenings, the OGTT will then be repeated | Other | Study arm |
Primary outcome
Change in 2 hour glucose in OGTT
Time frame: 3-7 working days
Change of the 2 hour glucose value in an oral glucose tolerance test
8 secondary outcomes
Change of the fasting glucose values
Time frame: 3-7 working days
Change in 1h glucose in OGTT
Time frame: 3-7 working days
Number of values changing from diabetic to non-diabetic values per patient
Time frame: 3-7 working days
Number of individuals converting from diabetic to non-diabetic OGTT / fasting glucose
Time frame: 3-7 working days
Change in plasma insulin fasting
Time frame: 3-7 working days
Change in plasma insulin 1 hour during OGTT
Time frame: 3-7 working days
Change in plasma insulin 2 hour during OGTT
Time frame: 3-7 working days
Change in homeostasis model assessment (HOMA) Index between 1st and second OGTT
Time frame: 3-7 working days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ready-to-eat wholegrain porridge in people with Gestational Diabetes and Glucose Tolerance Impaired in Pregnancy, run by Stoffwechselzentrum Rhein - Pfalz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Azat Samigullin, MD (+49(0)062149096746, azat.samigullin@swzrp.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 2 hour glucose in OGTT (time frame: 3-7 working days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.