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Tirzepatide Impact Assessment Study

Tirzepatide Impact Assessment: Exploring Health and Wellness Outcomes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 weeks
  • Procedures mentioned: Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "A blood draw is collected to evaluate cholesterol, blood sugar, insulin, appetite hormones, and liver and kidney function markers, and to analyze gene activity (RNA sequencing) and metabolites, which are small molecules that reflect how the body is using energy and nutrients."
  • "Participants also complete online questionnaires about diet, disordered eating, stress, mental health, and quality of life."
  • "Participants also wear a Garmin device for two weeks following the baseline visit to monitor sleep, heart rate, and oxygen saturation."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares weight-loss medicine with a program of eating fewer calories and being more active. It looks at changes in heart health, how the body uses energy, and well-being over three months. It is for adults age 18 or older with a BMI of 27.5 or higher.

This study examines how two different weight-loss strategies affect heart and metabolic health, as well as changes at the molecular level in the body. One group includes adults who are starting a GLP-1 receptor agonist medication (i.e., semaglutide or tirzepatide) prescribed by their own doctor for weight loss. The other group includes adults who will participate in a structured lifestyle program combining a reduced-calorie diet with increased physical activity. Both groups complete assessments at the start of the study and again after three months. At each visit, participants have their weight, body composition, blood pressure, and resting metabolic rate measured. A blood draw is collected to evaluate cholesterol, blood sugar, insulin, appetite hormones, and liver and kidney function markers, and to analyze gene activity (RNA sequencing) and metabolites, which are small molecules that reflect how the body is using energy and nutrients. Participants also complete online questionnaires about diet, disordered eating, stress, mental health, and quality of life. Those in the lifestyle group attend three individual nutrition and physical activity counseling sessions over the course of the study. The main goals of the study are (1) to determine whether GLP-1 receptor agonist medication or lifestyle changes produce greater improvements in heart and metabolic health markers over three months; (2) to examine if GLP-1 receptor agonist medication or lifestyle changes produce greater improvement in disordered eating, stress, mental health, and quality of life; (3) to investigate if GLP-1 receptor agonist medication or lifestyle changes produce greater improvement in appetite-related hormones (i.e., ghrelin, GLP-1, insulin, leptin, and peptide YY); and (4) to explore whether the two approaches cause different changes in gene expression and metabolic profiles. This is a pilot study conducted at Texas Tech University's Nutrition and Metabolic Health Initiative clinic in Lubbock, Texas. Who can participate: Adults aged 18 years and older with a BMI of 27.5 or higher who are either starting semaglutide or tirzepatide therapy for weight management or who are seeking weight management without the use of weight-loss medications. Who cannot participate: Individuals who are pregnant or lactating, have a pacemaker or internal medical device, have certain serious medical conditions (such as active cancer, uncontrolled hypertension, or severe kidney disease), have type 1 diabetes, or use insulin for type 2 diabetes.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • BMI of 27.5 or higher. BMI is a measure based on height and weight.
  • Medicine group: starting semaglutide or tirzepatide for weight loss, prescribed by your own doctor.
  • Lifestyle group: seeking weight loss without medicine and have not used any weight-loss medicine in the past 3 months.

Who can't join

  • Pregnant or breastfeeding.
  • Have a pacemaker or another medical device inside your body.
  • Have had chronic kidney disease in the past 2 years.
  • Have active cancer or had cancer treatment in the past 6 months.
  • Have a major condition affecting hormones, inflammation, the heart, or the brain and nerves. The study lists conditions such as thyroid disease, heart failure, stroke, autism, multiple sclerosis, Crohn's disease, and ulcerative colitis.
  • Have type 1 diabetes or use insulin for type 2 diabetes.
  • Have uncontrolled high blood pressure.
  • Lifestyle group only: starting weight-loss medicine now or started it within the past 3 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age 18 years or older * BMI of 27.5 kg/m2 or higher * For GLP-1 RA arm: initiating semaglutide or tirzepatide for weight loss as prescribed by their own medical provider * For LS comparator arm: not currently taking a GLP-1 receptor agonist or other weight-loss medication, and no use of weight-loss medication within the past 3 months Exclusion Criteria: * Pregnant * Breastfeeding * Wears a pacemaker or other internal medical device * Chronic kidney disease in the past 2 years * Active cancer or cancer treatment within the past 6 months * Current diagnosis of any major endocrine, inflammatory, cardiovascular, or neurological disorder/condition, including Addison's disease, autism, congestive heart failure, Crohn's disease, Cushing's syndrome, hyperparathyroidism, multiple sclerosis, neuromuscular disorders (Guillain-Barre syndrome or myasthenia gravis), stroke, thyroid gland disorders (hyperthyroidism or hypothyroidism), type 1 diabetes, and ulcerative colitis * Insulin therapy for type 2 diabetes * For LS comparator arm only: initiating any weight-loss medication (including a GLP-1 receptor agonist) currently or within the past 3 months

Study sites (1)

TX