Status:
RECRUITING
Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients
Lead Sponsor:
University of California, San Diego
Conditions:
Colitis, Ulcerative
Obesity
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Approximately 20-40% of patients with ulcerative colitis (UC) are obese. The investigators have demonstrated that obesity adversely impacts disease course in patients with UC, leading to higher risk o...
Eligibility Criteria
Inclusion
- adults aged 18-80y
- BMI ≥30kg/m\^2
- established diagnosis of UC based on clinical and endoscopy evidence corroborated by histopathology report
- active UC (Mayo Clinic score \[MCS\], 6-12; or active disease based on rectal bleeding score \[RBS\]=2 or 3 and stool frequency score=2 or 3) or dependent on corticosteroids (unable to taper below 10mg prednisone equivalent, or flaring within 2 months of stopping prednisone)
- starting a new biologic agent (TNFα antagonists, vedolizumab, ustekinumab) or flaring despite stable maintenance dose of biologic agent
- stable weight (\<5kg weight change) for preceding 4 weeks prior to screening and randomization
- able to speak or understand English and provide written informed consent.
Exclusion
- pregnant or lactating women
- prisoners
- current or history of toxic megacolon, abdominal abscess, symptomatic intestinal or colonic stricture, history of colectomy or diverting stoma, short bowel syndrome, active tuberculosis or other bacterial infections, cancer
- any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise patient safety
- clinically meaningful laboratory abnormalities, including significant anemia (Hb\<8g/dl), leukopenia (\<3x10\^9/L), thrombocytopenia (\<100K) or thrombocytosis (\>600K), ALT/AST \>3x upper limit of normal, creatinine \>2x upper limit of normal
- blood pressure \>140/95mmHg (ok to include if BP controlled on anti-hypertensives), fasting blood glucose \>240mg/dl or HbA1c \>9%, fasting triglycerides \>400mg/dl at randomization, type 1 diabetes, coronary artery disease, stroke, or other symptomatic peripheral arterial disease
- history of nephrolithiasis (H/O kidney stone \>1 time, and kidney stone within 1y prior to start of study), hyperthyroidism, seizure disorder
- recurrent major depression, presence or history of suicidal behavior or ideation with intent to act, current substantial depressive symptoms (patient health questionnaire-9, ≥10), use of antidepressant medication that has not been stable for the prior 3 months (bupropion-treated patients will be excluded)
- history of (or treatment for) glaucoma or increased intraocular pressure
- prior bariatric surgery; \>5 kg weight fluctuation in preceding 4 weeks, use of very-low-calorie diet, or participation in a formal weight loss program in the 3 months prior to the study
- smoking cessation within previous 3 months or plans to quit during the study period
- history of eating disorder or drug/alcohol abuse within the preceding 1 year concomitant use of other sympathomimetic medications, for example for ADHD
- known allergy to study medication
Key Trial Info
Start Date :
December 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04721873
Start Date
December 18 2020
End Date
June 30 2024
Last Update
May 16 2023
Active Locations (1)
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1
University of California San Diego
La Jolla, California, United States, 92037