Effects of Metformin Therapy on Pancreatic and Hepatic Fat Content Using 3.0 Tesla Magnetic Resonance Imaging Proton Density Fat Fraction Software in Patients of T2DM: Prospective Open Label Case Control 16 Weeks Proof of Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- To assess the effect of metformin on Pancreatic fat and hepatic fat in T2DM patients.
研究概览
简要总结
A sample size of 15 patients with T2DM 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). All these patients will undergo 2 weeks diet and exercise run in period using standard guidelines. 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)18,19. 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 females21. Each eligible subject will undergo ultrasonography of liver and pancreas before recruitment. Following ultrasonography, patients fulfilling the inclusion will be randomised to receive the 10 mg of Dapagliflozin as mentioned previously. Biochemistry, ultrasonography, DEXA, MRI, will be performed at baseline and at 4 months post intervention.
详细描述
A chronic metabolic disorder described by continuous hyperglycemia we call Diabetes mellitus or DM. this metabolic disorder could be for various reasons like resisting to marginal action of insulin, also could be due to diminished secretion of insulin, or maybe both. This Chronic hyperglycemia could be responsible for other kinds of abnormalities and therefore damage various organs in the patient, sometimes this also could even be life threatening complications.
NAFLD (Nonalcoholic fatty liver disease) has the highest incidence rate among obese and diabetic patients. In various studies, it has been found that Type 2 diabetes mellitus (T2DM) and nonalcoholic fatty liver disease (NAFLD) exist together which is a metabolic disorder. It has been found that the occurrence of NAFLD is 59.67% among T2DM patients with nonalcoholic steatohepatitis (NASH), simple steatosis (NAFL), and cirrhosis.
The studies reveal that NAFLD of 70% is usually found among T2DM patients. It is also observed that obesity and insulin resistance is correlated with NAFLD.
Noninvasive assessment and staging of disease are based on clinical parameters such as age, sex, liver function test, platelet count, lipid profile, BMI, and imaging modalities such as USG, Fibro-scan (FS), and magnetic resonance imaging mass spectroscopy. Such clinical scoring systems and TE are useful in the early detection of NAFLD and predicting fibrosis. The principle behind the management of NAFLD with T2DM involves an indirect effect through improvement in IR and glycemia and thus is used for the treatment of T2DM as well.
In addition to this, fatty pancreas is gaining importance from the research point of view. Study done by our group also showed that subcutaneous and intra-abdominal obesity, including fatty liver and pancreatic volume, were larger in non-obese Asian Indians with type 2 diabetes than in BMI-matched non-diabetic participants, whereas peripheral subcutaneous adiposity was lower. A study done in animal model shows that metformin exerted a beneficial effect in limiting beta-proliferation caused by high fat diet (HFD) fed to mice and also improved insulin resistance. Another study also showed similar effects of Metformin therapy, as it decreased the amount of fat in the liver in parallel with an improvement in the metabolic parameters and may, thus, be beneficial for preventing the late consequences of NAFLD in newly diagnosed diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight & obese (BMI 23.0 -35 kg/m2) subjects aged 30-60 years with T2DM of less than 5 year duration with HbA1c 6.5% to 9% & on a stable dose of metformin and/or sulphonylureas over last 8 weeks, fatty liver on ultrasound.
排除标准
- •The sample patient excluded in this study who had following medical history like: hypoglycaemia, diabetic abscess/ulcers, ketoacidosis, pregnant or lactating women, women planning for pregnancy/gestational diabetes, severe cardiac and renal disease, patients with renal transplant /undergoing immunosuppressive therapy for renal transplant ,substantial alcohol consumption, Child-Pugh B/C cirrhosis, other causes of liver disease, confounding concomitant drug use (including insulin, incretin mimetics, thiazolidinediones, vitamin E), and disorders such as a medical history of pancreatitis, pancreatic lipomatosis or pancreatic calculi (as detected by ultrasonography) ,type 1 diabetes mellitus.
研究组 & 干预措施
Treatment
T2DM patients will be provided with metformin in a specified dose
干预措施: Metformin (Drug)
结局指标
主要结局
To assess the effect of metformin on Pancreatic fat and hepatic fat in T2DM patients.
时间窗: 120 days
T2DM patients will undergo MRI, Ultrasound and Fibroscan testing to determine the level of fat in pancreas and liver.
次要结局
未报告次要终点
研究者
Dr Anoop Misra
Director
Diabetes Foundation, India