Role of Repetitive Transcranial Magnetic Stimulation in treating Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.Weight change in kilograms.
研究概览
简要总结
The metabolic syndrome, which covers a wide variety of pathological concerns, is rapidly becoming a global pandemic.
The metabolic syndrome (syndrome X, insulin resistance syndrome) consists of a constellation of metabolic abnormalities that confer increased risk of cardiovascular disease (CVD). Metabolic syndrome is defined as the occurrence of three abnormal results out of five components: elevated waist circumference, elevated triglycerides, reduced high density lipoprotein cholesterol, elevated blood pressure, and elevated fasting plasma glucose.
Current therapeutic options for metabolic syndrome are limited to individual treatment for hypertension, hyperglycemia and hypertriglyceridemia, as well as dietary control measures and regular exercise, including water-based training.
Repetitive transcranial magnetic stimulation (rTMS) is a safe and non-invasive neuromodulation technique that may reduce the food craving levels in obese patients by changing cortical brain activity. TMS alone or in combination with other anti-obesity approaches may open new ways to sustain the efficacy of weight control interventions.
As part of this pilot study, the parameters like weight change, changes in food craving levels, and cardiometabolic risk factors like fasting lipid levels, total cholesterol, high-density lipoproteins, low-density lipoproteins, fasting glucose levels and high sensitivity C- reactive protein, along with food craving questionnaires will be measured at the end of the therapy and on three follow up visits at the end of fifteen days, one month and three months after the end of the therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Agemorethan18 years 2.NCEP ATP III (any 3 or more of 5) criteria for metabolic syndrome: a)Central obesity:greaterthanorequalto108 cm (Male),greaterthanorequalto 88 cm (Female) b)Hypertriglyceridemia: Triglycerides greaterthanorequalto 150mg/dl or specific medication c)Low HDL cholesterol:lessthanorequalto 40mg/dl (Male) and lessthanorequalto 50mg/dl (Female) or specific medication.
- •d)Hypertension: Blood pressure greaterthanorequalto 130 mm Hg systolic or greaterthanorequalto 85 mm Hg diastolic or specific medication.
- •e)Fasting plasma glucose greaterthanorequalto 100mg/dl or specific medication or previously diagnosed type 2 diabetes.
- •3.Ability to follow verbal or written instructions.
排除标准
- •1.Axis-I and II psychiatric disorders according to DSM criteria 5 (such as Major Depression, Bipolar Disorder, or Attention Deficit Disorder) 2.IQ score less than 85 3.Organic brain disorders: history of stroke, brain major surgery or head trauma.
- •4.Pregnancy or lactation, absence of medically approved contraceptive methods in females of childbearing potential.
- •5.Serious or poorly controlled diseases (hepatic, renal or heart failure, atrial fibrillation or other heart rhythm disorders, uncontrolled diabetes).
- •6.History of any drug addiction, substance abuse or alcoholism.
- •7.Metal in any part of the head or body (implanted infusion pumps, intracardiac devices like pacemaker, heart valves) except dental fillings.
- •8.History of epilepsy or a family history of epilepsy among first-degree relatives.
- •9.Medications associatedwith lowered seizure threshold (such as antidepressants, anxiolytics…) 10.Recent use of anti-obesity medications or very-low-calorie diet (within 3 months prior to therapy or at any time during data collection).
- •11.Patients affected by galactosemia, priapism and terminal illness.
- •Patients on fluid restriction for SIADH or other conditions.
结局指标
主要结局
1.Weight change in kilograms.
时间窗: Immediately after completing 12 sessions of intervention. | Then at interval of 15 days,1 month and 3 months.
2.Changes in food craving levels.
时间窗: Immediately after completing 12 sessions of intervention. | Then at interval of 15 days,1 month and 3 months.
次要结局
- 1.Changes in Random Blood Glucose levels.(2.Changes in Glycated Haemoglobin levels.)
研究者
Dr Mohd Zaki Siddiqui
MLB Medical college and associated hospital