Standard of Care or Weight Loss Drug Therapy in Obesity-related Hypertension Pilot Study

What this Trial Is About

Hypertension is a leading cause of death worldwide and is closely linked to obesity, especially in young adults. This research evaluates the impact of weight loss on blood pressure in overweight or obese adults aged 18 to 40 with stage 1 hypertension. It compares current standard care, which includes antihypertensive medications and lifestyle advice, to weight loss achieved through the drug tirzepatide. The study aims to understand how much blood pressure can be lowered by these treatments and how quickly the effects occur. Participants are randomly assigned to one of two groups: one group receives tirzepatide, a combined GLP-1 and GIP receptor agonist, with doses increasing from 2.5 mg to 10 mg over 24 weeks; the other group follows standard care including lifestyle advice and up to one antihypertensive medication. The weight loss group receives tirzepatide for 6 months, while the standard care group is observed over 6 months. The study uses a modified trial within cohort design at a hospital clinical pharmacology and hypertension service. Throughout the 24-week study, participants undergo multiple assessments including ambulatory and clinic blood pressure measurements, body composition analysis, heart and vascular function tests, blood and urine tests, and quality of life questionnaires. Researchers monitor changes in blood pressure, weight, heart rate, hormone levels, kidney function, and medication use. This detailed follow-up helps determine the safety and effectiveness of weight loss through tirzepatide compared to standard treatment for obesity-related hypertension.

A Trial Within Cohort Feasibility Study Design Comparing Standard of Care Versus Weight Loss (Achieved Through Tirzepatide) for Obesity-related Hypertension in Young Adults