The Effect of Exercise and Tirzepatide on Weight and Health Outcomes (EXER-MED)

Обзор

This is clinical trials is to evaluate the effect of exercise with weight loss medication compared to weight loss alone. The study will enroll 24 adults from 30-65 years old with overweight or obesity. The main questions it will answer includes: * Does exercise combined with weight loss medication reduce body weight and body fat more than weight loss medication alone * Does exercise combined with weight loss medication improve other risk factors more such as the sugar in the blood, cholesterol, fitness, and quality of life Participants will: * Take a weight loss medication (tirzepatide) monthly under the supervision of their primary care physician * (Exercise group only) Will perform exercise \~3 times a week at the University of Virginia). Walking on a treadmill and resistance training * Visit the study site at the beginning of the study and after the study to evaluate weight, body fat, and other health measures

Подробное описание

The new type class of weight loss medications called GLP-1 medications have been shown to cause weight loss and improve risk factors for heart disease and diabetes. One thing that is currently unknown is whether exercise augments the impact of weight loss in people taking GLP-1 medication. The EXER-MED study is a pilot study evaluating the effect of 16 weeks of exercise training with GLP-1 medication compared to taking the medication alone. We will evaluate the impact of the study groups on weight, body composition (percent fat, percent lean mass), blood pressure, arterial stiffness, blood work (cholesterol, blood pressure, glucose, insulin) and quality of life.

Вмешательства

• Препарат Tirzepatide
  Participants will take tirzepatide under the care of their primary care provider for 16 weeks
• Поведенческое Exercise
  Participants will perform a combination of aerobic and resistance training for 16 weeks

Первичные конечные точки

• Weight [Срок оценки: Baseline and 16 Weeks]

Вторичные конечные точки (12)

• Physical activity level [Срок оценки: Baseline and 16 weeks]
• Changes in Blood Lipids Concentrations [Срок оценки: Baseline to 16 weeks]
• Resting Metabolic Rate [Срок оценки: Baseline and 16 Weeks]
• Change in Fasting Glucose Level [Срок оценки: Baseline to 16 Weeks]
• Change in Fasting Insulin Level [Срок оценки: Baseline to 16 Weeks]
• Change in Augmentation Index [Срок оценки: Baseline to 16 Weeks]
• Changes in Blood Pressure (mmHg) [Срок оценки: Baseline to 16 weeks]
• Change in hemoglobin A1C [Срок оценки: Baseline and Week 16]
• Change in Waist Circumference [Срок оценки: Baseline to Week 16]
• Change in Body Composition (Fat mass or Lean Mass) [Срок оценки: Baseline to Week 16]
• Change in Cardiorespiratory Fitness [Срок оценки: Baseline and 16 Weeks]
• Change in dietary quality [Срок оценки: Baseline to Week 16]

Критерии участия

Критерии включения

• Men and women 30-65 years of age, postmenopausal women included
• 27-29.9 with an additional CVD risk factor or 30-40 kg/m2
• For overweight adults only: additional cardiometabolic risk factor (diagnosed dyslipidemia, hypertension)
• Willingness and adequate health to go on weight loss medication
• The capability and willingness to provide written informed consent
• Approval of their primary care provider to go on weight loss medication

Критерии исключения

• Including but not limited to serious arrhythmias
• Cardiomyopathy
• Congestive heart failure
• Stroke or transient ischemic attacks
• Peripheral vascular disease
• Previous history of myocardial infarction or stroke
• Previous diagnosis or taking medication for type 1 or 2 diabetes, fasting glucose >125 mg/dL or HbA1C ≥6.5%
• Systolic blood pressure >160 mmHg and diastolic blood pressure >100 mmHg.
• Hospitalization for mental illness within the past 5 years or currently undergoing treatment for severe mental illness
• Conditions that can be aggravated or are contraindicated by exercise training
• Plans to be out of town more than 3 weeks in the next 4 months.
• Currently pregnant or plans to become pregnant
• Currently in a diet or exercise program
• Non-compliance during screening or extreme difficulty in obtaining baseline blood samples
• Enrolled in a different exercise program
• Previous weight loss surgery
• Use of weight loss medication within the last year
• hypo/hyper thyroid (medicated or unmedicated)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Virginia — Charlottesville

Идентификаторы

NCT: NCT07298915 · 302929

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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