The low indexes of metabolism intervention trial (LIMIT): design and baseline data of a randomized controlled clinical trial to evaluate how alerting primary care teams to low metabolic values, could affect the health of patients aged 75 or older

Abstract

Abstract Background Too-low body mass index (BMI), HbA1c% or cholesterol levels predicts poor survival. This study investigates whether e-mails about these low values, improve health of people older than 75 years. Methods LIMIT - an open label randomized trial - compares usual care to the addition of an e-mail which alerts the family physicians and nurses to low metabolic indexes of a specific patient and advises on nutritional and medical changes. Participants: Clalit Health Services (CHS) patients in the Northern and Southern Districts, aged ≥75 years with any of the following inclusion criteria: a. Significant weight loss: BMI < 23 kg/m2 with BMI drop of ≥2 kg/m2 during previous two years and without dietitian counseling during previous year. b. Tight diabetic control: HbA1c% ≤ 6.5% and received anti-diabetic medicines during previous 2 months. c. Drug associated hypocholesterolemia: total cholesterol <160 mg/dL and received cholesterol-lowering medicines during previous 2 months. Excluded from criterion c, were patients diagnosed with either ischemic heart disease, transient ischemic attack or stroke. The primary outcome was death from any cause, within one year. In a population of 48,623 people over the age of 75 years, 8584 (17.7%) patients were identified with low metabolic indices and were randomized to intervention or control groups. E-mails were sent on November 2015 to physicians and nurses at 383 clinics. Discussion Low metabolic reserve is common in people in Israel’s peripheral districts aged ≥75 years. LIMIT may show whether alerting primary care staff is beneficial. Trial registration ClinicalTrials.gov NCT02476578 . Registered on June 11, 2015.

Keywords

• Weight loss
• Dietetics
• Diabetes mellitus
• Glycated Hemoglobin A
• Cholesterol Deficiency (hypocholesterolemia)
• Iatrogenic disease