Hydration for Reducing Side Effects of GLP-1 RA Therapy
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a 17 - week study consisting of a one - week run - in period and a 16 - week intervention. The 16 - week pilot interventions aims to increase hydration in those beginning GLP - 1 RA therapy. Investigators aim to increase hydration to potentially decrease side effect severity, amount of side effects, and drug discontinuation associated with GLP - 1 RA therapy. The investigators are piloting to assess feasibility and preliminary efficacy of the intervention through examining participant retention, participant feedback, researcher and participant adherence to protocols, impact on hydration biomarkers, and participant reported GLP - 1 RA side effects.
Who Is on the Research Team?
Katherine N Balantekin, PhD, RD
Principal Investigator
University at Buffalo
Elizabeth G Mietlicki-Baase, PhD
Principal Investigator
University at Buffalo
Leonard H Epstein, PhD
Principal Investigator
University at Buffalo
Are You a Good Fit for This Trial?
This trial is for adults aged 18-60 who have just started a GLP-1 RA medication (within the past week), can speak English, and are willing to follow the study instructions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Participants undergo a one-week run-in period to establish baseline measurements
Intervention
Participants receive hydration intervention to increase hydration and potentially decrease side effects of GLP-1 RA therapy
Follow-up
Participants are monitored for safety and effectiveness after the intervention
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares increased hydration versus usual care in people starting GLP-1 RA therapy. It lasts 17 weeks, with participants randomly assigned to either drink more fluids or continue as normal, to see if better hydration reduces side effects from the medication.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The hydration plus group will receive the following behavior change strategies/techniques: coaching (consisting of goal setting, making a plan, and coping planning), positive feedback, and follow a contingency management payment schedule.
Participants assigned to the control group will receive all information as the Hydration Plus (experimental) group, but will not receive any behavior change strategies or technique training/materials.
Find a Clinic Near You
Who Is Running the Clinical Trial?
State University of New York at Buffalo
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
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