Status:
COMPLETED
Effects of a High Protein Diet on Clinical Outcomes in Heart Failure
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
University of California, Los Angeles
Conditions:
Heart Failure
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This research project was designed to study the role of dietary modifications in heart failure (HF) patients that suffer from type 2 diabetes mellitus and obesity. Specifically, the purpose of this st...
Detailed Description
Clinical management of heart failure (HF) related to obesity and diet recommendations currently lacks a strong scientific basis, and clinicians are divided in their approach to diet recommendations fo...
Eligibility Criteria
Inclusion
- obese (BMI \> 27 kg/m2);
- history of type 2 DM or documented impaired fasting glucose (IFG) according to fasting plasma glucose levels of 100-125 mg/dl or meeting 3 out of 4 criteria or Metabolic Syndrome ( as defined by the International Diabetes Federation 2011
- evaluation of HF and optimization of medical therapy; and
- ischemic or idiopathic HF etiology.
Exclusion
- age ≤18 years old;
- history of clinically significant illness including acute myocardial infarction or sustained ventricular arrhythmia in the prior 3 months or current liver, respiratory, and/or gastrointestinal disease and malignancy;
- pregnancy or lactation;
- serum creatinine level \> 1.5 mg/dl;\*
- currently participating in a supervised weight loss program;
- physician refusal to permit patient participation in the study; and
- weight loss of \>6% in the last 6 months
- gout or history of gout
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01423266
Start Date
December 1 2009
End Date
December 1 2015
Last Update
May 23 2016
Active Locations (1)
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1
University of California Medical Center
Orange, California, United States, 92868