Status:
COMPLETED
Developing an Adaptive Lifestyle Intervention Program in Family Medicine Clinics
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Insulin Resistance
Obesity
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate the feasibility of conducting a multicomponent lifestyle intervention research study within the UAB Family Medicine Clinic at Highlands and to obtain prelim...
Eligibility Criteria
Inclusion
- Male or female
- Any race or ethnicity
- BMI \>27 kg/m2
- Presence of 1 or more mild-to-moderate obesity-associated metabolic complications (i.e., Stage 1 Obesity)
- Prediabetes, type 2 diabetes (see exclusion criteria for additional details), metabolic syndrome, dyslipidemia, hypertension, non-alcoholic fatty liver disease
- Stable medication type and dosage for ≥3 months
Exclusion
- If type 2 diabetes,
- Currently prescribed metformin or prescribed within previous 3 months
- HbA1c concentration of \>12%
- Using exogenous insulin
- Pregnant or lactating within the past 6 months or trying to become pregnant
- Prescription for weight loss medications within the past 3 months
- Severe obesity-related complications that require immediate and more intensive clinical therapy (e.g., pharmacotherapy and/or bariatric surgery) as determined by study physician and/or referring practitioner at UAB Family Medicine Clinic.
- History of kidney disease that may increase the risk of lactic acidosis with metformin.
- Currently prescribed the following medications that may increase the risk of lactic acidosis with metformin: acetazolamide (Diamox), dichlorphenamide (Keveyis), methazolamide, topiramate (Topamax, in Qsymia), or zonisamide (Zonegran).
- Does not have a life-sustaining medical implant such as a pacemaker.
Key Trial Info
Start Date :
April 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04392284
Start Date
April 19 2021
End Date
June 3 2022
Last Update
October 3 2025
Active Locations (1)
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1
UAB Highlands Family and Community Medicine Clinic
Birmingham, Alabama, United States, 35205