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

NCT07233434 | Recruiting

• 1 other identifier: PAP_RI2_2019/07
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Non-Diabetic

Keywords

oral glucose tolerance; type 2 diabetes mellitus; Fasting blood glucose; HbA1c; screening

Outcome Measures

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

  baseline, 12 months

Secondary Outcomes (5)

• diabetic and non-diabetic subjects according to oral glucose tolerance

  baseline

• explanatory factors

  Baseline

• type 2 diabetes mellitus after 1 year

  12 months

• fasting blood glucose

  12 months

• oral glucose tolerance

  12 months

Study Arms (1)

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%.

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

Interventions

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.

non diabetic

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead

Study Sites (1)

Centre Hospitalier Universitaire de la Guadeloupe

Pointe-à-Pitre, Guadeloupe, 97159, Guadeloupe

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Fritz-Line VELAYOUDOM, Doctor

  CHU de la Guadeloupe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie HAMONY-SOTER

CONTACT

+590 590 93 46 77; valerie.soter@chu-guadeloupe.fr

Eunice NUBRET

CONTACT

eunice.nubret@chu-guadeloupe.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: February 2, 2021
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): August 2, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)