Nutritional, Metabolic, Endocrine: Obesity Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
This is a randomised controlled study of intensive diet with weight loss against non-intervention in obese patients with heart failure. The non-intervention group is included to provide information on
Sponsors
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Eligibility
Inclusion criteria
Inclusion criteria: 38 patients. Pilot study: 6 patients will be recruited for active dietary intervention. Main study: 24 patients will be recruited for the active dietary intervention and 8 patients for the control. Inclusion criteria: 1. Obese patients defined at body mass index (BMI) of above 30 and <40 kg/m2 (excessive body weight will preclude exercise and accurate imaging) 2. Stable heart failure patients of NHYA (New York Heart Association) class II or III (patients must be able to undertake exercise testing). Diagnosis of heart failure will be based on standard criteria of symptoms of more than 6 months with confirmed LVEF impairment on echocardiogram 3. Age above 25 and below 70 years (to ensure patients can participate with the exercise etc)
Exclusion criteria
Exclusion criteria: 1. Unable to give informed consent 2. Subjects with renal impairment defined by creatinine >170 ?mol/l (inappropriate to include patients with more complex illness in this study). 3. Patients with Diabetes Mellitus on antidiabetic medication (other than metformin - diet and weight loss would require alteration of insulin or non-metformin diabetes treatment, complicating assessments) 4. Heart failure patients of NHYA (New York Heart Association) class III (patients must be able to undertake exercise testing)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak oxygen consumption during cardiopulmonary exercise testing (Peak VO2) following acute weight loss (week 6) and weight loss maintenance phase(16 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed