Status:
WITHDRAWN
Community-based CBT and T2D in Latino Population
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 2 Diabetes
Mental Health Issue
Eligibility:
All Genders
35-65 years
Phase:
NA
Brief Summary
The purpose of this project is to develop and test the acceptance and clinical efficacy of a cognitive behavioral therapy (CBT)-based lifestyle intervention, to help manage obesity and diabetes-relate...
Detailed Description
We will implement a CBT-based lifestyle intervention program, among Latino adults with T2D, that targets appropriate body weight, glycemic control, blood pressure, plasma triglyceride, and emphasizes ...
Eligibility Criteria
Inclusion
- i) HbA1c ≥ 6.5% and ≤ 10% at screening; ii) 35 to 65 years old; iii) self-reported Hispanic and/or Latino/a/x heritage; iv) Able to speak and read Spanish; v) obese, defined as BMI 27.0 kg/m2 to 45.0 kg/m2; vi) no change in medications for the past three months; and vii) stable weight (defined as \<4% change in body weight) for the past two months.
Exclusion
- i) treatment with basal insulin \>0.5units/kg/day; ii) treatment with rapid acting (prandial) insulin iii) Type 1 diabetes; iv) severe cardiovascular disease defined as: previous stroke, decompensated heart failure New York Heart Association class III or IV, myocardial infarction, unstable angina pectoris, or coronary arterial bypass graft or angioplasty; v) severe pulmonary, renal, or liver disease; vi) active substance abuse with alcohol or drugs by self-report; vii) active tobacco use (\>8 cigarettes/day); viii) excessive alcohol consumption (\>14 drinks per week for women or 21 drinks per week for men); ix) treatment with non-diabetes medications (e.g., corticosteroids, anti-psychotics) known to have metabolic/body weight effects that could affect the outcome measures or increase the risk of study procedures; x) history of bariatric surgery; xi) poorly controlled hypertension (SBP ≥160 mmHg or DBP ≥110 mmHg); xii) structured exercise \>120 minutes/week; xiii) pregnant, lactating, not using effective birth control if premenopausal, or planning to become pregnant within the 12-month study period; xiv) unstable weight (\>4% change in the last 2 months); xv) anemia (hemoglobin \<10 g/dL); xvi) has a continuous glucose monitor (CGM) or plans to have a CGM in the next 12 months; xvii) major psychiatric illness that would interefer with study participation; and xviii) any person that is unable to provide informed consent or unwilling to complete the study or who, for any reason, the research team considers an inappropriate candidate for the study.
Key Trial Info
Start Date :
December 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05222373
Start Date
December 7 2023
End Date
April 9 2024
Last Update
July 10 2025
Active Locations (1)
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1
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105