NCT07740291 · Texas Tech University
Tirzepatide Impact Assessment Study
(TIA)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
GLP-1 Receptor Agonist Therapy
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.
BEHAVIORAL
Structured Lifestyle Intervention
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.
Primary outcome measures
Change in Fasting Blood Glucose
Time frame: Baseline and 3 months
Fasting serum blood glucose measured from venipuncture sample and analyzed as part of the basal metabolic panel. Used as the reference outcome for power estimation; a between-group difference of 4.71 mg/dL was the minimum detectable effect based on a prior semaglutide meta-analysis (SD = 9.9 mg/dL).
Change in LDL Cholesterol
Time frame: Baseline and 3 months
Serum LDL cholesterol measured from a fasting venipuncture sample. A decrease of 10% or more from baseline is considered clinically meaningful.
Change in Triglycerides
Time frame: Baseline and 3 months
Serum triglycerides measured from fasting venipuncture sample. A decrease of 30% or more from baseline is considered clinically meaningful.
Change in Fasting Insulin
Time frame: Baseline and 3 months
Serum fasting insulin measured from venipuncture sample. Used alongside fasting glucose to characterize insulin resistance.
Change in Blood Pressure
Time frame: Baseline and 3 months
Systolic and diastolic blood pressure measured using a digital monitor after a five-minute rest period. The average of two readings taken five minutes apart is recorded.
Change in Disordered Eating
Time frame: Baseline and 3 months
Disordered eating characteristics including dietary restraint, eating concern, shape concern, and weight concern assessed using the Eating Disorder Examination Questionnaire (EDE-Q) administered via Qualtrics.
Change in Food Addiction
Time frame: Baseline and 3 months
Food addiction symptom count and severity assessed using the Modified Yale Food Addiction Scale Version 2.0 (mYFAS 2.0) administered via Qualtrics.
Change in Alcohol Use
Time frame: Time Frame: Baseline and 3 months
Alcohol use frequency, quantity, and disorder risk assessed using the Alcohol Use Disorders Identification Test (AUDIT) and a 30-day frequency and quantity measure administered via Qualtrics.
Change in Substance Use
Time frame: Time Frame: Baseline and 3 months
Tobacco and other substance use assessed using the Lifetime Smoking Questionnaire and a 30-day frequency and quantity of substance use measure administered via Qualtrics.
Change in Depressive Symptoms and Suicidal Ideation
Time frame: Time Frame: Baseline and 3 months
Depressive symptom severity and suicidal ideation assessed using the Patient Health Questionnaire-9 (PHQ-9) administered via Qualtrics.
Change in Anxiety
Time frame: Baseline and 3 months
Generalized anxiety symptom severity assessed using the Generalized Anxiety Disorder-7 (GAD-7) administered via Qualtrics.
Change in Perceived Stress
Time frame: Baseline and 3 months
Perceived psychological stress assessed using the Perceived Stress Scale (PSS) administered via Qualtrics.
Change in Fatigue
Time frame: Baseline and 3 months
Fatigue severity assessed using the Fatigue Assessment Scale (FAS) administered via Qualtrics.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Lubbock, Texas
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 31, 2026 · Source of record for eligibility and locations