Screening for Type 2 Diabetes by Oral Glucose Tolerance Test in the Population Groups Not Diagnosed by Fasting Blood Glucose in Guadeloupe

ConditionNon-Diabetic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCentre Hospitalier Universitaire de la Guadeloupe

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

    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 control of the HbA1c levels will be also performed associated with a physical examination.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: non diabeticExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

explanatory factors

Odd-ratio of explanatory factors for T2DM defined by the OGTT

Time frame
Baseline
3

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
4

fasting blood glucose

Sensitivity, specificity, positive and negative predictive value of fasting blood glucose after 1 year

Time frame
12 months

Other outcomes

Sponsors and contacts

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