Health Condition 1: E889- Metabolic disorder, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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. 12.Contraindications to perform the Magnetic Resonance Imaging (MRI).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Weight change in kilograms. 2.Changes in food craving levels. Timepoint: Immediately after completing 12 sessions of intervention. Then at interval of 15 days,1 month and 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in Random Blood Glucose levels. 2.Changes in Glycated Haemoglobin levels. 3.Changes in Cholesterol levels. 4.Changes in Triglyceride levels. 5.Changes in high sensitivity C-reactive protein levels. 6.Changes in Cortisol levels. Timepoint: Total Duration of study is 120 days from start of therapy after screening | — |
Countries
India
Contacts
MLB Medical college and associated hospital