Glucose Tolerance Impaired in PregnancyNCT03623412
Women With Minor Degrees of Glucose Intolerance and the Postpartum Glucose Tolerance Test
A study testing 75g oral glucose tolerance test and 75g GTT in people with Glucose Tolerance Impaired in Pregnancy, run by Clalit Health Services.
Trial summary
The aim of this study is to offer a 75g postpartum glucose tolerance test to women with minor degrees of glucose intolerance and to assess if these women are significantly different from women who were diagnosed as GDM (Gestational Diabetes Mellitus) Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Glucose Tolerance Impaired in Pregnancy
- What is being tested?
- 75g oral glucose tolerance test and 75g GTT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2018to 30 Sep 2019
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy women (without pre-existing diabetes) who underwent an OGTT during pregnancy
Who cannot join
- pre-existing diabetes, or failed to perform the OGTT
About this study
Official title: Women With Minor Degrees of Glucose Intolerance and the Postpartum Glucose
The aim of this study is to offer a 75g postpartum glucose tolerance test to women with minor degrees of glucose intolerance and to assess if these women are significantly different from women who were diagnosed as GDM (Gestational Diabetes Mellitus)
- Conditions
- Glucose Tolerance Impaired in Pregnancy
- Being tested
- 75g oral glucose tolerance test, 75g GTT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
75g oral glucose tolerance testDiagnostic test
Women with one abnormal value in the OGTT during pregnancy (minor degree of glucose intolerance) will be offered a post-partum 75g GTT (Glucose Tolerance Test), similar to that offered to women with GDM
75g GTTDiagnostic test
post-partum GTT
| Study group | Role | What they receive |
|---|---|---|
| One abnormal value | Experimental | Women with only one abnormal value on OGTT (Oral Glucose Tolerance Test) during pregnancy Receives: Diagnostic Test: 75g oral glucose tolerance test |
| GDM | Active comparator | Women with two abnormal values on OGTT during pregnancy - diagnosis=GDM Receives: Diagnostic Test: 75g GTT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive post-partum GTT results
Measured: 6-12 weeks post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start15 Aug 2018 (estimated)
- Primary completion15 Sep 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Tolerance Impaired in PregnancyStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623412
- Sponsor's protocol ID
- 0068-18
- Status last verified
- Aug 2018
- First submitted
- 6 Aug 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women With Minor Degrees of Glucose Intolerance and the Postpartum Glucose
- ClinicalTrials.gov ID
- NCT03623412
- Acronym / sponsor ID
- 0068-18
- Conditions
- Glucose Tolerance Impaired in Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Study start
- 15 Aug 2018 (estimated)
- Primary completion
- 15 Sep 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 9 Aug 2018 (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 aim of this study is to offer a 75g postpartum glucose tolerance test to women with minor degrees of glucose intolerance and to assess if these women are significantly different from women who were diagnosed as GDM (Gestational Diabetes Mellitus)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One abnormal value | Experimental | Diagnostic Test: 75g oral glucose tolerance testWomen with only one abnormal value on OGTT (Oral Glucose Tolerance Test) during pregnancy |
| GDM | Active comparator | Diagnostic Test: 75g GTTWomen with two abnormal values on OGTT during pregnancy - diagnosis=GDM |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy women (without pre-existing diabetes) who underwent an OGTT during pregnancy
Key exclusion criteria (1 listed)
- pre-existing diabetes, or failed to perform the OGTT
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 |
|---|---|---|
| 75g oral glucose tolerance testWomen with one abnormal value in the OGTT during pregnancy (minor degree of glucose intolerance) will be offered a post-partum 75g GTT (Glucose Tolerance Test), similar to that offered to women with GDM | Diagnostic test | One abnormal value |
| 75g GTTpost-partum GTT | Diagnostic test | GDM |
Primary outcome
Positive post-partum GTT results
Time frame: 6-12 weeks post partum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
Related trials for Glucose Tolerance Impaired in Pregnancy
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Recruiting
A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP) and Follow Up PP CARE
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RecruitingPhase 3
Semaglutide for the Treatment of Glucose Intolerance in Women With Prior Gestational Diabetes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 75g oral glucose tolerance test and 75g GTT in people with Glucose Tolerance Impaired in Pregnancy, run by Clalit Health Services.
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 1 inclusion and 1 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 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive post-partum GTT results (time frame: 6-12 weeks post partum). 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 14 Aug 2018.