Tirzepatide Impact Assessment Study

Conditions

• Addiction
• Cardiometabolic Health Indicators
• Eating Disorders
• Mental Health
• Obesity & Overweight

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• GLP-1 Receptor Agonist Therapy — DRUG
  Participants receive semaglutide or tirzepatide as prescribed by their own medical provider prior to study enrollment. Dosing and titration followed the prescribing provider's clinical judgment and are not controlled by the study team. Both medications are GLP-1 receptor agonists approved for weight management and glycemic control; tirzepatide additionally acts on the glucose-dependent insulinotropic polypeptide (GIP) receptor.
• Structured Lifestyle Intervention — BEHAVIORAL
  A reduced-calorie diet providing a 500 kcal daily deficit from individually calculated total energy expenditure, combined with a goal of 150 to 300 minutes of moderate-intensity physical activity per week. Total energy expenditure is estimated by multiplying each participant's measured resting metabolic rate (MedGem indirect calorimetry) by a standard physical activity factor. Meal plans are based on the Academy of Nutrition and Dietetics Nutrition Care Manual. Three individual counseling sessions are delivered over three months in person or via a HIPAA-secured video platform.

Study Details

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.

Key Dates

First listed

Jul 31, 2026

Start date

Jan 2, 2025

Status verified

Jul 2026

Primary completion

Nov 23, 2026

Completion

Dec 7, 2026

Study Design

Enrollment

27 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Experimental: GLP-1 Receptor Agonist (Semaglutide or Tirzepatide)
  Individuals in this study arm will be prescribed semaglutide or tirzepatide for weight management by their primary medical provider. Individuals will be invited to enroll in the study if they are starting semaglutide or tirzepatide within 0-3 days of coming into the NMHI clinic for their baseline assessment.
• Active Comparator: Lifestyle Comparator Arm
  Participants receive a structured lifestyle intervention delivered by a nutritional sciences graduate student and developed by a Registered Dietitian. The intervention targets a 500 kcal daily deficit from measured total energy expenditure and 150 to 300 minutes of moderate-intensity physical activity per week. Three individual education sessions are provided at baseline, one month, and two months. Dietary adherence is monitored via MyFitnessPal or a food journal. The same physical assessments and biospecimen collection procedures as the GLP-1 RA arm are completed at baseline and three months.

Primary Outcome Measure

Change in Fasting Blood Glucose [ Time Frame: Baseline and 3 months ]

Locations (1)

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