To Identify Anytime Hyperglycaemia in Subjects With Normoglycaemia and Prediabetes

NCT05939895 | Recruiting

• 1 other identifier: CGMS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To test these hypotheses, The Investigators will recruit 100 overweight and obese adolescents with HbA1c ranging across the ADA classification spectrum from normal to prediabetes,(nearly 40:normoglycemi, 30: IFG, 30:1GT) measure free-living glucose by continuous glucose monitoring (CGM), and assess the relationships among CGM outcomes, HbA1c, and OGTT results (FPG and 2-h glucose). Individual with overt diabetes will be excluded. This will be a 2 visit study. Subjects will be coming to Fortis CDOC after a minimum 8-hour overnight fast. Informed written consent and validated questionnaire in a language known to them (English/Hindi) will be obtained from all participants. Clinical details will be obtained from the case records of the patients. Note of visible markers of insulin resistance (acanthosis nigricans, buffalo hump, double chin, subcutaneous fat pads, skin) Anthropometry, skinfolds \& blood pressure will be recorded. Overweight and, obesity will be defined according to predefined guidelines for Asian Indian. Abdominal obesity is defined as waist circumference of ≥ 90 centimetres (cms) in males and ≥ 80 cms in females. A blinded iPro Continuous Glucose Monitor (Medtronic MiniMed, Inc) will be inserted. After a calibration period of 1 hour, fasting laboratory result will be collected: FPG, HbA1c. HbA1c will be done by HPLC (NGSP approved, turbid inhibition immunoassay). Then subjects will consume 1.75 g/kg glucose, maximum 75 g (glucose beverage) and will have a second venepuncture 2 hours later for plasma glucose measurement. While awaiting the 2-hour venepuncture, participants will be provided instructions on CGM device care and calibration. Participants will be instructed to wear the CGM device for a minimum of 72 hours and to not change any of their current dietary or activity habits for the period of CGM wear. They will be trained to use a glucose monitor and collect capillary blood glucose values at least three times daily, prior to meals. Participants will also be asked to complete a simple log of their activity, as well as record dietary intake, and sleep and wake times. The iPro and log-sheet will be returned in person after a minimum of 72 hours of recording time. Investigators and patients will be kept blinded to CGM recordings throughout the study. Daily glycaemic variability will be assessed by the change in the mean amplitude of glucose excursions (MAGE) index, and through the standard deviation (SD) of the mean 24-hour blood glucose concentration. Day-to-day variability will be assessed through the mean of daily differences (MoDD in mg/dL). Daily glycaemic control will be assessed by the mean (M) daily CGM value, as well as by the times (in minutes/day) spent in optimal glycaemic range (70-140 mg/dL) and above predefined hyperglycaemic thresholds (140 ,180 and 200 mg/dL) together with the corresponding area under the curve (AUC) values. In addition, areas under 24-hour glycaemic traces (AUCs) will be analysed to estimate: overall hyperglycaemia (defined asAUC≥100 mg/dL over the full 24-hour period = AUCtotal);postprandial hyperglycaemia (AUC\[0-4 h\], i.e. for four-hour periods after each of the main meals and, if considered relevant by the core laboratory, after additional snacks = AUCpp); and basal hyperglycaemia, i.e. overall hyperglycaemia - postprandial hyperglycaemia (AUCb)

Conditions

Healthy

Keywords

Non Diabetic; Prediabetes

Outcome Measures

Primary Outcomes (1)

• To diagnose missed cases of prediabetes.

  In addition, areas under 24-hour glycaemic traces (AUCs) will be analysed to estimate: overall hyperglycaemia (defined as AUC≥100 mg/dL over the full 24-hour period = AUC total); postprandial hyperglycaemia (AUC \[0-4 h\], i.e., for four-hour periods after each of the main meals and, if considered relevant by the core laboratory, after additional snacks = AUC pp); and basal hyperglycaemia, i.e., overall hyperglycaemia - postprandial hyperglycaemia (AUC b)

  5 days

Interventions

Medtronic G3 sensor DEVICE

A Sensor is fitted on the arm and abdomen of every patient and using a CGMS App. the patient's blood glucose level are monitored at regular intervals.

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with normoglycemia and prediabetes visiting Fortis CDOC Hospital.

You may qualify if:

• Age -30-60 yrs
• BMI- \>23- 35Kg/m2

You may not qualify if:

• Hypothyroidism on treatment.
• Substantial alcohol consumption (\>20 g/day for women or \>30 g/day for men).
• Current smoker
• Concomitant confounding drug use (steroid, vit E)

Sponsors & Collaborators

• Diabetes Foundation, India: lead
• National Diabetes Obesity and Cholesterol Foundation: collaborator

Study Sites (1)

Fortis CDOC Hospital

New Delhi, National Capital Territory of Delhi, 110048, India

RECRUITING

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

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

Study Officials

• AMRITA GHOSH, MBBS

  Fortis CDOC Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ANOOP MISRA, MD

CONTACT

01149101222; anoopmisra@gmail.com

AMRITA GHOSH, MBBS

CONTACT

01149101222; dramritaghosh@outlook.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 11, 2023
• Study Start: January 1, 2020
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)