To Identify Anytime Hyperglycaemia in Subjects With Normoglycaemia and Prediabetes
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ClinicalTrials.gov Identifier: NCT05939895 |
Recruitment Status :
Recruiting
First Posted : July 11, 2023
Last Update Posted : February 20, 2024
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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)
Condition or disease | Intervention/treatment |
---|---|
Healthy | Device: Medtronic G3 sensor |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Other |
Time Perspective: | Other |
Official Title: | To Identify Anytime Hyperglycaemia in Subjects With Normoglycaemia and Prediabetes |
Actual Study Start Date : | January 1, 2020 |
Estimated Primary Completion Date : | May 30, 2024 |
Estimated Study Completion Date : | June 30, 2024 |
- Device: Medtronic G3 sensor
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.
- To diagnose missed cases of prediabetes. [ Time Frame: 5 days ]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)
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Ages Eligible for Study: | 30 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Age -30-60 yrs
- BMI- >23- 35Kg/m2
Exclusion Criteria:
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05939895
Contact: ANOOP MISRA, MD | 01149101222 | anoopmisra@gmail.com | |
Contact: AMRITA GHOSH, MBBS | 01149101222 | dramritaghosh@outlook.com |
India | |
Fortis CDOC Hospital | Recruiting |
New Delhi, Delhi, India, 110048 | |
Contact: Anoop Misra, MD 01149101222 anoopmisra@gmail.com | |
Principal Investigator: Amrita Ghosh, MBBS | |
Sub-Investigator: Anoop Misra, MD |
Principal Investigator: | AMRITA GHOSH, MBBS | Fortis CDOC Hospital |
Responsible Party: | Dr Anoop Misra, Director, Diabetes Foundation, India |
ClinicalTrials.gov Identifier: | NCT05939895 |
Other Study ID Numbers: |
CGMS |
First Posted: | July 11, 2023 Key Record Dates |
Last Update Posted: | February 20, 2024 |
Last Verified: | February 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Non Diabetic Prediabetes |
Hyperglycemia Prediabetic State Glucose Intolerance Glucose Metabolism Disorders |
Metabolic Diseases Diabetes Mellitus Endocrine System Diseases |