Non-DiabeticDIADEGNCT07233434
Screening for Type 2 Diabetes by Oral Glucose Tolerance Test in the Population Groups Not Diagnosed by Fasting Blood Glucose in Guadeloupe
A study testing After inclusion, the subjects will have an OGTT performed in the department of Diabetology. If the glucose blood levels remain normal after the OGTT, the test will be repeated after 12 months. A contr in people with Non-Diabetic, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
Trial summary
In France, only the fasting blood glucose (FBG) measurement is recommended for diabetes screening. Ethnic heterogeneity and genetic polymorphisms specific to the Afro-Caribbean and Indo-Caribbean population in Guadeloupe justify the interest to early screen type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Diabetic
- What is being tested?
- After inclusion, the subjects will have an OGTT performed in the department of Diabetology. If the glucose blood levels remain normal after the OGTT, the test will be repeated after 12 months. A contr
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGuadeloupe
- Study dates
- 2 Feb 2021to 2 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- Inclusion criteria : Adult subject (over 18 years and under 65 years old) Subjects of African or Indian origin and self-declared Normal FBG levels (110mg/dL) HbA1c levels between 5.7 and 6.4% One or more of the following factors: BMI > 25 kg/m2, family history of T2DM in the 1st and 2nd familial degree, hypertension, dyslipidemia.
Affiliation to the national social health system or equivalent Informed and written consent signed by the patient and the investigator (at the latest on the day of inclusion and before the completion of any research related exam)
- Exclusion criteria : Pregnant or lactating woman Women with a history of gestational diabetes Polycystic ovary syndrome Endocrine, hepatic or renal diseases affecting glycemic control Treatment that affect the metabolism of glucose or insulin Refusal to participate Subjects without adequate or impaired decisional abilities for consent to research and placed under guardianship, curatorship or safeguard of justice, person participating in another research including an exclusion period still in progress, severely impaired physical and / or psychological health, which, according to the investigator, may affect the compliance of the study participant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eunice NUBRET contact
Guadeloupe1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de la Guadeloupe
Pointe-à-Pitre, Guadeloupe, 97159
Valérie HAMONY-SOTER, +590590934686, valerie.soter@chu-guadeloupe.fr
Eunice NUBRET, 0590934686, eunice.nubret@chu-guadeloupe.fr
About this study
Official title: Screening for Type 2 Diabetes by Oral Glucose Tolerance Test in the Population Groups Not Diagnosed by Fasting Blood Glucose in Guadeloupe: a Pilot Study
In France, only the fasting blood glucose (FBG) measurement is recommended for diabetes screening. Ethnic heterogeneity and genetic polymorphisms specific to the Afro-Caribbean and Indo-Caribbean population in Guadeloupe justify the interest to early screen type 2 diabetes mellitus (T2DM). Our main objective is to estimate the prevalence of T2DM defined by oral glucose tolerance (OGTT) in subjects with risk factors for T2DM and not diagnosed with the FBG.
Read the detailed description
Contrary to the French recommendations, the American recommendations for the diagnosis of T2DM, include FBG, HbA1c or OGTT. These recommendations suggest that there are differences in the HbA1c levels between subjects of African origin and Caucasian subjects. The population in Guadeloupe is characterized by ethnic heterogeneity with genetic polymorphisms specific to the subjects of African and Indian origin that could justify the interest of a targeted and early screening of T2DM by another test than FBG. The main dilemma is how to confirm that subjects with risk factors of T2DM but normal FBG are not diabetic? Some of them have normal FBG levels but HbA1c levels between 5.7 and 6.4% that are not used as diagnostic criteria in France. We think that OGTT could help to better diagnose T2DM in such subjects.
After identifying these subjects, an OGTT will be performed after inclusion. The diagnosis of T2DM will be confirmed in subjects who exceeded the glucose threshold of 11mmol/L (200mg/dL), 2 hours after the OGTT.
The number of these diabetic subjects is evaluated to 10%, they will be treated according to the HAS recommendations and monitored during the year of the study. The other subjects without abnormalities will be followed at 12 months with OGTT repetition.
- Conditions
- Non-Diabetic
- Being tested
- After inclusion, the subjects will have an OGTT performed in the department of Diabetology. If the glucose blood levels remain normal after the OGTT, the test will be repeated after 12 months. A contr
- Keywords
- oral glucose tolerance, type 2 diabetes mellitus, Fasting blood glucose, HbA1c, screening
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
After inclusion, the subjects will have an OGTT performed in the department of Diabetology. If the glucose blood levels remain normal after the OGTT, the test will be repeated after 12 months. A contrDiagnostic test
After inclusion, the subjects will have an OGTT performed in the department of Diabetology. If the glucose blood levels remain normal after the OGTT, the test will be repeated after 12 months. A control of the HbA1c levels will be also performed associated with a physical examination.
| Study group | Role | What they receive |
|---|---|---|
| non diabetic | Experimental | After inclusion, the subjects will have an OGTT performed in the department of non-diabetic subjects in Guadeloupe, from African or Indian origin who have risk factors of diabetes associated with normal FBG levels but HbA1c levels between 5.7 and 6.4%. Receives: Diagnostic Test: After inclusion, the subjects will have an OGTT performed in the department of Diabetology. If the glucose blood levels remain normal after the OGTT, the test will be repeated after 12 months. A contr |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c levels > 5.7%,
Percentage of patients with HbA1c levels > 5.7%, who exceeded the glucose threshold of 11mmol/L (200mg/dL), 2 hours after the oral glucose toleranceand who were not diagnosed with fasting blood glucose
Measured: baseline, 12 months
Secondary outcomes (5)
diabetic and non-diabetic subjects according to oral glucose tolerance
Percentage of diabetic and non-diabetic subjects according to OGTT by age, gender, presence of metabolic syndrome, ethnic origin and biological data
Measured: baseline
explanatory factors
Odd-ratio of explanatory factors for T2DM defined by the OGTT
Measured: Baseline
type 2 diabetes mellitus after 1 year
Percentage of non-diabetic subjects who develop a T2DM after 1 years of follow-up.
Measured: 12 months
fasting blood glucose
Sensitivity, specificity, positive and negative predictive value of fasting blood glucose after 1 year
Measured: 12 months
oral glucose tolerance
Sensitivity, specificity, positive and negative predictive value of oral glucose tolerance after 1 year.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start2 Feb 2021
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-DiabeticStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- After inclusion, the subjects will have an OGTT performed in the department of Diabetology. If the glucose blood levels remain normal after the OGTT, the test will be repeated after 12 months. A control of the HbA1c levels will be also performed associated with a physical examination.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fritz-Line VELAYOUDOM, Doctor, Principal investigator, CHU de la Guadeloupe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233434
- Sponsor's protocol ID
- PAP_RI2_2019/07
- Acronym
- DIADEG
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Type 2 Diabetes by Oral Glucose Tolerance Test in the Population Groups Not Diagnosed by Fasting Blood Glucose in Guadeloupe: a Pilot Study
- ClinicalTrials.gov ID
- NCT07233434
- Acronym / sponsor ID
- DIADEG / PAP_RI2_2019/07
- Conditions
- Non-Diabetic
- Keywords
- oral glucose tolerance, type 2 diabetes mellitus, Fasting blood glucose, HbA1c, screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Aug 2028 (estimated)
- First posted
- 18 Nov 2025 (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.
In France, only the fasting blood glucose (FBG) measurement is recommended for diabetes screening. Ethnic heterogeneity and genetic polymorphisms specific to the Afro-Caribbean and Indo-Caribbean population in Guadeloupe justify the interest to early screen type 2 diabetes mellitus (T2DM). Our main objective is to estimate the prevalence of T2DM defined by oral glucose tolerance (OGTT) in subjects with risk factors for T2DM and not diagnosed with the FBG.
Detailed description
Contrary to the French recommendations, the American recommendations for the diagnosis of T2DM, include FBG, HbA1c or OGTT. These recommendations suggest that there are differences in the HbA1c levels between subjects of African origin and Caucasian subjects. The population in Guadeloupe is characterized by ethnic heterogeneity with genetic polymorphisms specific to the subjects of African and Indian origin that could justify the interest of a targeted and early screening of T2DM by another test than FBG. The main dilemma is how to confirm that subjects with risk factors of T2DM but normal FBG are not diabetic? Some of them have normal FBG levels but HbA1c levels between 5.7 and 6.4% that are not used as diagnostic criteria in France. We think that OGTT could help to better diagnose T2DM in such subjects.
After identifying these subjects, an OGTT will be performed after inclusion. The diagnosis of T2DM will be confirmed in subjects who exceeded the glucose threshold of 11mmol/L (200mg/dL), 2 hours after the OGTT.
The number of these diabetic subjects is evaluated to 10%, they will be treated according to the HAS recommendations and monitored during the year of the study. The other subjects without abnormalities will be followed at 12 months with OGTT repetition.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- After inclusion, the subjects will have an OGTT performed in the department of Diabetology. If the glucose blood levels remain normal after the OGTT, the test will be repeated after 12 months. A control of the HbA1c levels will be also performed associated with a physical examination.
| Arm | Type | Receives |
|---|---|---|
| non diabetic | Experimental | Diagnostic Test: After inclusion, the subjects will have an OGTT performed in the department of Diabetology. If the glucose blood levels remain normal after the OGTT, the test will be repeated after 12 months. A contrAfter inclusion, the subjects will have an OGTT performed in the department of non-diabetic subjects in Guadeloupe, from African or Indian origin who have risk factors of diabetes associated with normal FBG levels but HbA1c levels between 5.7 and 6.4%. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| After inclusion, the subjects will have an OGTT performed in the department of Diabetology. If the glucose blood levels remain normal after the OGTT, the test will be repeated after 12 months. A contrAfter inclusion, the subjects will have an OGTT performed in the department of Diabetology. If the glucose blood levels remain normal after the OGTT, the test will be repeated after 12 months. A control of the HbA1c levels will be also performed associated with a physical examination. | Diagnostic test | non diabetic |
Primary outcome
HbA1c levels > 5.7%,
Time frame: baseline, 12 months
Percentage of patients with HbA1c levels > 5.7%, who exceeded the glucose threshold of 11mmol/L (200mg/dL), 2 hours after the oral glucose toleranceand who were not diagnosed with fasting blood glucose
5 secondary outcomes
diabetic and non-diabetic subjects according to oral glucose tolerance
Time frame: baseline
explanatory factors
Time frame: Baseline
type 2 diabetes mellitus after 1 year
Time frame: 12 months
fasting blood glucose
Time frame: 12 months
oral glucose tolerance
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Eunice NUBRET contact
Fritz-Line VELAYOUDOM, Doctor principal investigator
CHU de la Guadeloupe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing After inclusion, the subjects will have an OGTT performed in the department of Diabetology. If the glucose blood levels remain normal after the OGTT, the test will be repeated after 12 months. A contr in people with Non-Diabetic, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 18 Nov 2025. 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 Guadeloupe. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valérie HAMONY-SOTER (+590 590 93 46 77, valerie.soter@chu-guadeloupe.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c levels > 5.7%, (time frame: baseline, 12 months). 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 18 Nov 2025.