Establishing Pancreatic Fat Content and Pancreatic Volume in Person of Normal glucose tolerance, impaired glucose tolerance and Type 2 Diabetes Mellitus
- Conditions
- Type 2 diabetes mellitus without complications,
- Registration Number
- CTRI/2023/06/054228
- Lead Sponsor
- NA
- Brief Summary
T2DM among Asian Indians is characterized by onset at a younger age, greater intra-abdominal obesity at relatively lower BMI, greater insulin resistance and early decline in beta cell function. (1) The pancreas plays a key role in diabetes mellitus, in the context of insulin resistance and beta cell dysfunction. Autopsy studies report deficits in β-cell mass ranging from 0 to 65% in type 2 diabetes (T2DM), and ∼70–100% in type 1 diabetes (T1DM), and, when evaluated, increased β-cell apoptosis in both T1DM and T2DM.(2)
Pancreatic anatomy has not been researched extensively in connection with Type 2 diabetes mellitus. Previous studied has shown that pancreatic volume is lesser in person with diabetes when compared to person without diabetes.(3) Imaging studies are expected to produce reliable information regarding pancreas size. However, while some studies using ultrasound (US), computed tomography (CT), and magnetic resonance imaging (MRI) to assess pancreas size in diabetes have shown reduced pancreatic size in individuals with diabetes as compared to controls. (4,5)
In the only two studies done in India, our group reported ectopic fat deposition in liver & pancreas (using pancreatic volume as surrogate of pancreatic fat) using MRI, in young, non-obese Asian Indians with T2DM. Specifically, we reported that following volumes were higher in non-obese subjects with T2DM as compared to non-obese, normoglycemic subjects viz; total abdominal fat (19.4%), total intra-abdominal fat (49.7%), intra-peritoneal fat (47.7%), retroperitoneal fat (70.7%) and pancreatic volume (26.6%). Further pancreatic volume index (21.3 %) and liver span (10.8%) were comparably higher in cases than in controls. In addition to this, we also reported significant positive correlations for pancreatic volume with BMI, waist and hip circumferences, waist-to-hip ratio, subcutaneous and intra-abdominal fat, and increased liver span (as a surrogate of NAFLD). (6) We predicted higher risk of diabetes with pancreatic volume ≥ 55cm3. (7) In our recently published study in patient with T2DM with BMI 31.36±4.44 Kg/m2 we reported baseline pancreatic fat 7.52±5.84% by the usage of MRI PDFF. (8)
**Rationale of the study**:
It is debated if presence of excess fat in pancreatic may cause apoptosis of beta cells, and/or dysregulation of beta-cell function and its removal may restore insulin sensitivity in patients with type 2 diabetes. Studies claim pancreatic fat increases with aging and obesity, it is not increased in type-2 diabetes. (9) The main limitation is assessment of pancreatic volume and fat fraction as it is time consuming and costly. There are gaps in our knowledge in this interesting and emerging area of pancreatic volume. That is why we need to establish normative data of pancreatic volume and pancreatic fat for our population.
We aim to establish normative data of pancreatic volume and pancreatic fat in following population
1. Obese and non-obese person with normal glucose tolerance
2. Obese and non-obese person with impaired glucose tolerance
3. Obese and non-obese person with type 2 diabetes
**Methodology:**
**Inclusion criteria**:
- Normal and Overweight (BMI < 23.0 and ≥25 kg/m2) 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
- Normal and Overweight (BMI < 23.0 and ≥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.
- Normal and Overweight (BMI < 23.0 and ≥25 kg/m2) subjects aged 20-50 years with impaired Glucose tolerance matched for age, weight and sex.
**Exclusion criteria:**
- T2DM patients with poor glycaemic control (HbAâ‚c> 9∙0%), hypoglycaemia, diabetic abscess/ulcers, ketoacidosis, pregnant or lactating women, women planning for pregnancy/gestational diabetes,
- Subjects with severe cardiac and renal disease, patients with renal transplant /undergoing immunosuppressive therapy for renal transplant ,
- Substantial alcohol consumption (>20 g/day for women or >30 g/day for men),
- History of pancreatitis, pancreatic lipomatosis or pancreatic calculi (as detected by ultrasonography) ,
- Subjects with type 1 diabetes mellitus,
- T2DM Subjects requiring major drug intervention to maintain good glycemic control will be excluded.
- Subjects with metallic implants, pacemaker leads, radioactive seeds or surgical staples in the body will be excluded for the study
**Study design**: A sample size of total 18 patients( 6 patients with T2DM and 6 persons with impaired glucose tolerance and 6 with normal glucose tolerance) visiting Fortis C DOC Hospital will be recruited with informed, written consent and will be requested to answer a validated questionnaire in a language known to them (English/Hindi). Clinical details will be obtained from the case records of the patients. Anthropometry, skinfolds & blood pressure will be recorded as mentioned in previous studies from our group (see below for details) Overweight and, obesity will be defined according to predefined guidelines for Asian Indians20. Abdominal obesity is defined as waist circumference of ≥ 90 centimetres (cms) in males and ≥ 80 cms in females.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 45
- 1:- Normal and Overweight (BMI < 23.0 and ≥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 < 23.0 and ≥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 < 23.0 and ≥25 kg/m2) subjects aged 20-50 years with impaired Glucose tolerance matched for age, weight and sex.
- 1:- T2DM patients with poor glycaemic control (HbAâ‚c> 9∙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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To establish pancreatic volume in normoglycemic , impaired glucose tolerant and person with type 2 diabetes mellitus. 365 days
- Secondary Outcome Measures
Name Time Method To establish pancreatic volume in normoglycemic , impaired glucose tolerant and person with type 2 diabetes mellitus. 365 days
Trial Locations
- Locations (1)
Fortis CDOC Hospital
🇮🇳South, DELHI, India
Fortis CDOC Hospital🇮🇳South, DELHI, IndiaDr AMERTA GHOSHPrincipal investigator01149101222dramritaghosh@outlook.com