Health Condition 1: null- Diabetes Mellitus Type 2
Conditions
Interventions
Intervention1: Soya protein powder: During the first 6 months, Almased (Soya protein powder with yogurt, diluted with 250 ml of water) will be given as a meal replacement substituting one major meal/d
the dosage will be defined individually according to body weight. During the next 6 months, Almased (50 g/d) will be added to the diet before one meal. The Almased group will receive group sessions re
Sponsors
Almased Wellness GmbH
Eligibility
Inclusion criteria
Inclusion criteria: 1-Type 2 diabetes mellitus: Diabetes mellitus will be determined by medical records, current treatment, verification from personal health care provider, or test results meeting the 2010 American Diabetes Association criteria of fasting glucose >=126 mg/dl, symptoms of hyperglycemia with casual plasma glucose > 200 mg/dl or two-hour plasma glucose >=200 mg/dl after a 75 gram oral glucose load. Individuals who have a clinical history strongly suggestive of type1 diabetes will be excluded. Individuals taking oral hypoglycemic medication with diet and exercise are eligible. Subjects taking insulin will not be eligible for entry into the study. 2-Body mass index: Overweight and obese individuals, with body mass index 25 â?? 40 kg/m2, are eligible. Weight loss is recommended for overweight diabetic participants with one or more cardiovascular risk factors. 3-Age: Individuals older than 21 years are eligible. 4-Ethnicity: All ethnic groups are eligible for the study. 5-Blood pressure :AMDIT will enrol individuals whose blood pressure is under at least moderate control: Treated or untreated resting systolic/diastolic blood pressure less than 160/100 mmHg. Individuals whose blood pressure exceeds these levels during screening will be advised to seek treatment and may be re-evaluated following initiation of antihypertensive treatment. 6-Glycemic control: AMDIT will enrol individuals whose HbA1c is between 8 and 10%. Individuals whose HbA1c exceeds this level may require more urgent care and will be told to seek treatment and may also be re-evaluated for inclusion. 7-Lipid control: Individuals with a fasting triglycerides concentration less than 500 mg/dl are eligible. 8-History of cardiovascular disease :AMDIT will recruit individuals both with and without a history of cardiovascular disease. Data from NHANES III indicate that approximately 20-30% of individuals meeting the eligibility criteria defined by the trial will have a history of cardiovascular disease. Cardiovascular event rates in diabetic individuals with heart disease are expected to be approximately twice those of diabetic individuals without a history of heart disease. Participants with a history of uncomplicated myocardial infarction, coronary artery bypass surgery, percutaneous coronary angiography, atherectomy or stent placement, chronic stable angina pectoris and stable NYHA Class I or Class II congestive heart failure are eligible if they are beyond three months after intervention. Participants with a history of carotid or peripheral artery atherectomy, angioplasty, or bypass surgery are also eligible for inclusion if they meet functional criteria for inclusion. Participants will either undergo a supervised maximum exercise stress test or provide a document signed by her/his physician that she/he is able to participate (cf. form in Appendices). The exercise stress test, if needed, will be conducted while the participant is continued on any prescribed medication for cardiovascular disease. Abnormalities will result in exclusion or in further evaluation. Individuals who develop exercise induced angina pectoris or significant ST segment depression of 1.5 mm or greater at low to moderate workloads (less than 7 METs) may be included if they have been evaluated by a cardiologist and considered safe for participation in the lifestyle Intervention protocol. 9-Willingness to participate: Particip
Exclusion criteria
Exclusion criteria: Currently pregnant or nursing. Cancer requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer) HIV positive (self-report), due to effects on weight and body composition of HIV and medications used to treat HIV, active tuberculosis (self-report),Cardiovascular disease (heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months) Participants also will be excluded if they meet any of the following criteria: •unstable angina pectoris or angina pectoris at rest •a history of cardiac arrest •complex ventricular arrhythmia at rest or with exercise •uncontrolled atrial fibrillation (heart rate of 100 beats per minute or more) •NYHA Class III or IV congestive heart failure •acute myocarditis, pericarditis or hypertrophic myocardopathy •clinically significant aortic stenosis •left bundle branch block or cardiac pacemaker unless evaluated by a cardiologist •cardiac defibrillator •heart transplant •history of aortic aneurysm of at least 7 cm in diameter or aortic aneurysm repair •Resting heart rate less than 45 beats per minute or greater than 100 beats. Any abnormality during the maximum exercise stress test that indicates that is unsafe to participate in the Lifestyle Intervention (This includes angina pectoris or significant ST segment depression at low levels of exercise, unless evaluated and cleared for participation by a cardiologist; exercise induced ventricular arrhythmias; abnormal hemodynamics, such as flat or decreasing systolic blood pressure with increasing workload; and an abnormal response to exercise which, in the opinion of the exercise physiologist or physician, would make it unsafe for the individual to participate.) Those at moderate to high risk for cardiac complications during exercise and/or who are unable to self-regulate activity or understand the recommended activity level (The phrase moderate to high risk is defined according to AHA/ACSM criteria. Information for this determination is available from the medical history and the ECG performed during maximal exercise stress testing). Renal disease: urine dipstick protein of 4+ (equivalent to approximately 1 g/day), serum creatinine exceeding 1.4 mg/dl (women) or 1.5 mg/dl (men), or currently receiving dialysis Chronic obstructive pulmonary disease that would limit ability to follow the protocol (investigator judgment) Self-reported chronic hepatitis B or C or cirrhosis Inflammatory bowel disease requiring treatment in past year Cushingâ??s syndrome (clinic diagnosis or self-report) Acromegaly (clinical diagnosis or self-report) Amputation of lower limbs as result of non-traumatic causes Any major organ transplant (does not include cornea or hair transplants) Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the clinical site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c improvementTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| HOMA-Index (Homeostasis Model Assessment)improvement Improvent in Fasting blood glucose Improvent in Fasting blood insulin Timepoint: 1 year | — |
Countries
Brazil, Germany, India, United Kingdom, United States of America
Contacts
Public ContactDr R Manjunath
Vikram Hospital
Outcome results
None listed