Characterization of the "Transfusion-dependent Prediabetes" Using Continuous Glucose Monitoring

NCT06533618 | Completed

• 1 other identifier: Hemoglycare
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Dysglycemia is a frequent finding in transfusion-dependent thalassemia (TDT). The oral glucose tolerance test (OGTT) remains the only validated screening test, but the procedure is complex and time-consuming. Continuous glucose monitoring (CGM) systems are simple to use, and could have a role in the diabetes mellitus diagnosis. This study involved 39 participants (19 cases and 20 healthy controls) using CGM for the analysis of the glucose metrics. Participants resulted negative for diabetes mellitus screening tests. Patients' clinical data were compared with glucose metrics.

Conditions

Prediabetic State

Outcome Measures

Primary Outcomes (1)

• Number of participants with pre diabetes in Transfusion dependent patients

  Transfusion dependent patients were studied using a continuous glucose monitoring system with the aim to show condition of dysglicemia (prediabetes)

  Seven days

Study Arms (4)

Thalassemic patients

EXPERIMENTAL

Patient affected by TDD

Diagnostic Test: Continuous glucose monitoring system

Healthy controls

EXPERIMENTAL

caucasian; age ≥18 years; body mass index \<25.0 kg/m2; no chronic illness or medications that might affect glucose metabolism; fasting glycemia\<100 mg/dl; HbA1c \<5.7% (39 mmol/mol); no positive islet autoantibodies; HOMA-IR \<2.5

Diagnostic Test: Continuous glucose monitoring system

Euglycemic thalassemic patients

EXPERIMENTAL

Glucose metrics characteristic: (Time above range≥140 mg/dl: ≤ 6%)

Diagnostic Test: Continuous glucose monitoring system

Hyperglicemic thalassemic patients

EXPERIMENTAL

Glucose metrics characteristic: (Time above range≥140 mg/dl: \>6%)

Diagnostic Test: Continuous glucose monitoring system

Interventions

Continuous glucose monitoring system DIAGNOSTIC_TEST

All participants (subjects and controls) applied a Medtronic Guardian4 sensor for seven days.

Euglycemic thalassemic patients; Healthy controls; Hyperglicemic thalassemic patients; Thalassemic patients

Eligibility Criteria

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

You may qualify if:

• They were affected by transfusion-dependent thalassemia (TDT)
• They had a history of at least 10 years of therapy with red blood cell transfusions (transfusion frequency less than one months) and iron chelation therapy
• They tested negative for diabetes mellitus screening tests (fasting glycemia, OGTT).

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Centro di Diabetologia Pediatrica "G.Stoppoloni"

Naples, 80100, Italy

Location

Related Publications (4)

• Naberezhnykh GA, Khomenko VA, Krasikova IN, Kim NIu, Solov'eva TF. [Cooperative interaction between protein-porin and lipopolysaccharide]. Bioorg Khim. 1996 Sep;22(9):671-7. Russian.

  PMID: 8999784 BACKGROUND

• De Sanctis V, Soliman A, Yassin M. Iron overload and glucose metabolism in subjects with beta-thalassaemia major: an overview. Curr Diabetes Rev. 2013 Jul;9(4):332-41. doi: 10.2174/1573399811309040005.

  PMID: 23687960 BACKGROUND

• Karlen A, Johansson AM, Kenne L, Arvidsson LE, Hacksell U. Conformational analysis of the dopamine-receptor agonist 5-hydroxy-2-(dipropylamino)tetralin and its C(2)-methyl-substituted derivative. J Med Chem. 1986 Jun;29(6):917-24. doi: 10.1021/jm00156a008.

  PMID: 3712382 BACKGROUND

• Miller E, Polonsky WH, Miller K. What Role Might There Be for Continuous Glucose Monitoring in the Assessment of Diabetes Risk? Diabetes Technol Ther. 2023 Jun;25(S3):S14-S20. doi: 10.1089/dia.2023.0136.

  PMID: 37306445 BACKGROUND

MeSH Terms

Conditions

Prediabetic State

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Angela Zanfardino

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 1, 2024
• Study Start: July 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 30, 2023
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)