Status:
COMPLETED
Binge Eating and Chromium Study
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Alliance for Research on Schizophrenia and Depression
Conditions:
Binge Eating Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to test the feasibility and preliminary efficacy of a 6-month chromium picolinate (CrPic) treatment trial in binge eating disorder (BED).
Detailed Description
Binge eating (i.e., the consumption of unusually large amounts of food with a sense of loss of control) is a common problem with serious public health implications in large part due to its role in obe...
Eligibility Criteria
Inclusion
- Currently meets DSM-IV criteria for binge eating disorder (BED);
- Is able to provide informed consent and meet study visit requirements; and
- Is psychiatrically stable (e.g., no current suicidal or homicidal intent or other psychiatric condition that requires acute intervention).
Exclusion
- Body mass index (BMI) \< 24.9 kg/m\^2 (underweight or normal weight) or ≥ 40 kg/m\^2 (severely obese);
- Postmenopausal;
- Age \< 18 or \> 55 years;
- Pregnant, planning on becoming pregnant during the study period, or lactating;
- Current psychotropic medication use;
- Current use of insulin or other medications to control glucose metabolism;
- Current use of medications known to significantly influence appetite or weight \[i.e., over-the-counter appetite suppressants that contain phentermine or sibutramine, atypical antipsychotic agents with high weight gain liability (such as olanzapine, risperidone, etc), prednisone, etc.\];
- Fasting glucose level \> 126 mg/dL (indicative of diabetes); and
- Creatinine level indicating renal insufficiency (\> 1.0 for women; \> 1.2 for men).
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00904306
Start Date
July 1 2008
End Date
July 1 2011
Last Update
April 3 2012
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