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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
120
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.
Centre Hospitalier Universitaire de la Guadeloupe
Pointe-à-Pitre, Guadeloupe, Guadeloupe
RECRUITINGHbA1c 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
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