Atrial Fibrillation, Diabetes Mellitus, Type 2, Morbid Obesity, Obesity
Conditions
Keywords
obesity, fasting, diet
Brief summary
BACKGROUND AND RATIONALE Two out of three Americans are overweight and obesity is associated with hypertension, sleep apnea, atrial fibrillation. Metabolic syndrome with centripetal obesity is also a precursor to insulin resistance and the development of Type II diabetes mellitus. While multiple strategies for weight reduction are often recommended in physician visits, calculating calories and energy expenditure is often inconvenient and does not promote compliance. Intermittent fasting, or time-restricted eating, is a methods to limit caloric intake by fasting for 16 hours to promote ketosis and suppress insulin secretion. Weight loss and reduction in body fat has been observed with brief periods of intervention as time-restricted eating results in reduction in overall caloric intake. Prospective feasibility studies and randomized comparative trials with intermittent fasting are lacking. The investigators recommend caloric restriction in all of our patients that suffer from arrhythmias and BMI \>30. However, they have not systematically measured compliance and the efficacy of lifestyle interventions. Lifestyle counseling and weight loss has been shown to decrease the progression and burden of symptomatic atrial fibrillation. Intermittent fasting can result in consistent reductions in body fat and weight without specific lifestyle counseling. The aim of the present observation cohort study is to assess the feasibility of recommending intermittent fasting in an arrhythmia clinic with regard to compliance and efficacy. The investigators hypothesize that compliance and adherence to a 16/8 intermittent fasting regimen will be \>25% and result in weight loss, compared to the 6 month trend prior to the intervention. This pilot study will serve as the basis to power the first randomized trial comparing intermittent fasting with other types of dietary counseling for arrhythmia outcomes. OBJECTIVES To prospectively assess compliance to prescribed intermittent fasting, measured by adherence and change in weight at 6 months.
Interventions
BEHAVIORALIntermittent Fasting
Time restricted eating for 8 hours per day, with 16 hour fast. During the daily fast, patients are encouraged to drink water, black coffee, or green tea without sugar, cream, milk, or sweeteners.
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective observation study of lifestyle intervention with intermittent fasting (time-restricted eating) of 16 hours every day.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 * BMI≥ 30 * Ongoing evaluation and management of cardiac arrhythmias
Exclusion criteria
* Pregnant or nursing * Eating disorder or history of eating disorders (self-report) * Diabetic mellitus type 1 or insulin requiring type 2 diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight loss | 6 months | Patients will be weighed weekly for the first month and than have weight checks in clinic monthly |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | Monthly until 6 months | calculated from height and weight measured in clinic |
| Waist Circumference | Monthly until 6 months | measured by research specialist at umbilicus |
| Blood Pressure | Monthly until 6 months | measured in clinic by nursing staff |
| Quality of Life Assessment | 6 months | SF36 Questionnaire to be filled out by patient |
| Hemoglobin a1c | 6 months | Blood test in patients with diabetes mellitus |
Countries
United States
Outcome results
None listed