Screening for Type 2 Diabetes by Oral Glucose Tolerance Test in the Population Groups Not Diagnosed by Fasting Blood Glucose in Guadeloupe
Recruiting · NCT07233434 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Hospitalier Universitaire de la Guadeloupe
View the official record on ClinicalTrials.gov →Interventions studied
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 this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Centre Hospitalier Universitaire de la Guadeloupe - Pointe-à-Pitre, Guadeloupe, Guadeloupe