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Establishing Pancreatic Fat Content and Pancreatic Volume in Person of Normal glucose tolerance, impaired glucose tolerance and Type 2 Diabetes Mellitus

"Establishing Pancreatic Fat Content and Pancreatic Volume in Person of Normoglyceamia, Pre diabetes and Type 2 Diabetes Mellitus Using 3.0 Tesla Magnetic Resonance Imaging Proton Density Fat Fraction Software Protocol: Prospective Open Label proof of concept study"

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/06/054228
Enrollment
45
Registered
2023-06-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

None listed

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1:- Normal and Overweight (BMI =25 kg/m2) 2:- subjects aged 20-50 years with T2DM of less than 5 year duration with HbA1c 6.5% to 9% & on a stable dose of OHA (metformin and sulphonylurea) over last 8 weeks 3:- Normal and Overweight (BMI =25 kg/m2) subjects aged 20-50 years with normal Glucose tolerance matched for age, weight and sex and with no first-degree family history of diabetes. 4:- Normal and Overweight (BMI =25 kg/m2) subjects aged 20-50 years with impaired Glucose tolerance matched for age, weight and sex

Exclusion criteria

Exclusion criteria: 1:- T2DM patients with poor glycaemic control (HbAâ??c > 9â??0%), hypoglycaemia, diabetic abscess/ulcers, ketoacidosis, pregnant or lactating women, women planning for pregnancy/gestational diabetes, 2:- Subjects with severe cardiac and renal disease, patients with renal transplant /undergoing immunosuppressive therapy for renal transplant , 3:- Substantial alcohol consumption ( >20 g/day for women or >30 g/day for men), 4:- History of pancreatitis, pancreatic lipomatosis or pancreatic calculi (as detected by ultrasonography) , 5:- Subjects with type 1 diabetes mellitus, 6:- T2DM Subjects requiring major drug intervention to maintain good glycemic control will be excluded. 7:- Subjects with metallic implants, pacemaker leads, radioactive seeds or surgical staples in the body will be excluded for the study.

Design outcomes

Primary

MeasureTime frame
To establish pancreatic volume in normoglycemic , impaired glucose tolerant and person with type 2 diabetes mellitus.Timepoint: 365 days—

Secondary

MeasureTime frame
To establish pancreatic volume in normoglycemic , impaired glucose tolerant and person with type 2 diabetes mellitus.Timepoint: 365 days—

Countries

India

Contacts

Public ContactDr ANOOP MISRA

Fortis CDOC Hospital

anoopmisra@gmail.com01149101222

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 3, 2026