An interventional study of 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 Non-Diabetic, sponsored by Centre Hospitalier Universitaire de la Guadeloupe. Recruiting at 1 site in Guadeloupe. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by Centre Hospitalier Universitaire de la Guadeloupe · Not applicable, Interventional, and Diagnostic
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.
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 120 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Centre Hospitalier Universitaire de la Guadeloupe is the lead sponsor of 50 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
o 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) levels between 5.7 and 6.4% One or more of the following factors: > 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)
o 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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%.
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
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.
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
Time frame: baseline, 12 months
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
Time frame: baseline
explanatory factors
Odd-ratio of explanatory factors for T2DM defined by the OGTT
Time frame: Baseline
type 2 diabetes mellitus after 1 year
Percentage of non-diabetic subjects who develop a T2DM after 1 years of follow-up.
Time frame: 12 months
fasting blood glucose
Sensitivity, specificity, positive and negative predictive value of fasting blood glucose after 1 year
Time frame: 12 months
oral glucose tolerance
Sensitivity, specificity, positive and negative predictive value of oral glucose tolerance after 1 year.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2021 (actual). Primary completion is estimated for Feb 2027, 72 months after the start.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 72 months is above that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
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Centre Hospitalier Universitaire de la Guadeloupe