An interventional study of GLP-1 Receptor Agonist Therapy and Structured Lifestyle Intervention in Obesity & Overweight, Cardiometabolic Health Indicators and Addiction, sponsored by Texas Tech University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Texas Tech University · Not applicable, Interventional, and Other
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.
This prospective non-randomized comparative pilot study is conducted at the Nutrition and Metabolic Health Initiative (NMHI) clinic at Texas Tech University in Lubbock, Texas. The study includes two arms: a GLP-1 receptor agonist (GLP-1 RA) arm and a lifestyle (LS) comparator arm. GLP-1 RA arm participants are recruited from obesity medicine and aesthetics clinics in Lubbock, Texas, and enrolled within 0 to 3 days of initiating semaglutide or tirzepatide as prescribed by their own medical provider. LS comparator arm participants are recruited from the community via flyers, community events, hospital intranet postings, and university listservs; they will receive a structured behavioral intervention at no cost.
Each arm follows a two-visit assessment schedule at baseline and at three months. In-person visits include anthropometric measurement, bioelectrical impedance analysis for body composition, resting metabolic rate assessment via MedGem indirect calorimetry, blood pressure measurement (average of two readings after a five-minute rest), and venipuncture for biological sample collection. Blood is drawn into serum-separating tubes and an EDTA tube. Serum is processed for lipid panels, basal metabolic panels, hepatic and renal function markers including alanine aminotransferase, aspartate aminotransferase, total bilirubin, and creatinine, as well as appetite-related hormones including ghrelin, GLP-1, insulin, leptin, and peptide YY. The EDTA tube is processed for whole-blood RNA sequencing and untargeted metabolomics. Participants also wear a Garmin device for two weeks following the baseline visit to monitor sleep, heart rate, and oxygen saturation. Online questionnaires are completed via Qualtrics prior to each in-person visit.
LS comparator participants receive three individual lifestyle education sessions across the study period: at baseline, at one month, and at two months. Sessions may be completed in person or via a HIPAA-secured video platform and last approximately 30 to 45 minutes each. Each participant's total energy expenditure (TEE) is estimated by multiplying measured resting metabolic rate by a physical activity factor. Participants are instructed to follow a 500 kilocalorie daily deficit from TEE and to accumulate 150 to 300 minutes of moderate-intensity physical activity per week. Meal plans are based on the Academy of Nutrition and Dietetics Nutrition Care Manual. Dietary and physical activity adherence is monitored using MyFitnessPal or a food journal, with records reviewed at each session.
Given the pilot nature of this study, the primary emphasis is on effect size estimation and variance characterization to inform future adequately powered trials rather than definitive hypothesis testing. For example, with 12 participants in the GLP-1 receptor agonist arm and 15 participants in the LS comparator arm, the study is powered to detect only large between-group differences in cardiometabolic outcomes. Transcriptomic and metabolomic findings should be interpreted as hypothesis-generating. IRB approval was obtained prior to study initiation (IRB Number: IRB2024-370).
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 27 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Texas Tech University is the lead sponsor of 82 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: GLP-1 Receptor Agonist Therapy
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.
Behavioral: Structured Lifestyle Intervention
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.
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.
This study also gives Semaglutide, Tirzepatide. No intervention listed here names it: that was found by reading the record.
Change in Fasting Blood Glucose
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).
Time frame: Baseline and 3 months
Change in LDL Cholesterol
Serum LDL cholesterol measured from a fasting venipuncture sample. A decrease of 10% or more from baseline is considered clinically meaningful.
Time frame: Baseline and 3 months
Change in Triglycerides
Serum triglycerides measured from fasting venipuncture sample. A decrease of 30% or more from baseline is considered clinically meaningful.
Time frame: Baseline and 3 months
Change in Fasting Insulin
Serum fasting insulin measured from venipuncture sample. Used alongside fasting glucose to characterize insulin resistance.
Time frame: Baseline and 3 months
Change in Blood Pressure
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.
Time frame: Baseline and 3 months
Change in Disordered Eating
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.
Time frame: Baseline and 3 months
Change in Food Addiction
Food addiction symptom count and severity assessed using the Modified Yale Food Addiction Scale Version 2.0 (mYFAS 2.0) administered via Qualtrics.
Time frame: Baseline and 3 months
Change in Alcohol Use
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.
Time frame: Time Frame: Baseline and 3 months
Change in Substance Use
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.
Time frame: Time Frame: Baseline and 3 months
Change in Depressive Symptoms and Suicidal Ideation
Depressive symptom severity and suicidal ideation assessed using the Patient Health Questionnaire-9 (PHQ-9) administered via Qualtrics.
Time frame: Time Frame: Baseline and 3 months
Change in Anxiety
Generalized anxiety symptom severity assessed using the Generalized Anxiety Disorder-7 (GAD-7) administered via Qualtrics.
Time frame: Baseline and 3 months
Change in Perceived Stress
Perceived psychological stress assessed using the Perceived Stress Scale (PSS) administered via Qualtrics.
Time frame: Baseline and 3 months
Change in Fatigue
Fatigue severity assessed using the Fatigue Assessment Scale (FAS) administered via Qualtrics.
Time frame: Baseline and 3 months
Differential Gene Expression Profiles
Whole-blood RNA sequencing analyzed using DESeq2 to identify differentially expressed genes from baseline to 3 months within each arm and between arms. Gene Set Enrichment Analysis used to identify enriched biological pathways.
Time frame: Baseline and 3 months
Change in Plasma Metabolomic Signatures
Untargeted metabolomics conducted on plasma samples. Univariate and multivariate analyses including principal component analysis and partial least squares discriminant analysis performed using the MetaboAnalyst R package.
Time frame: Baseline and 3 months
Association Between Gene Expression Changes and Cardiometabolic Outcome Changes
Pearson or Spearman correlations and partial least squares regression used to examine associations between transcriptomic change scores and changes in lipid panel, blood glucose, insulin, and blood pressure within and between arms.
Time frame: Baseline and 3 months
Change in Dietary Intake
Dietary intake patterns assessed using the Short Food Frequency Questionnaire administered via Qualtrics.
Time frame: Baseline and 3 months
Change in Physical Activity
Self-reported physical activity level assessed using the Rapid Assessment of Physical Activity (RAPA) questionnaire administered via Qualtrics, with objective daily step count additionally tracked via Garmin Vivofit4 watch throughout the 3-month study period.
Time frame: Baseline and 3 months
Change in Sleep Duration
Nightly sleep duration tracked continuously via Garmin Vivofit4 watch, with participants syncing device data to the Garmin app at least weekly throughout the 3-month study period.
Time frame: Baseline and 3 months
Change in Health-Related Quality of Life
General health-related quality of life assessed using the WHO Health-Related Quality of Life (HRQOL) measure and gastrointestinal quality of life assessed using the Gastrointestinal Quality of Life questionnaire, both administered via Qualtrics.
Time frame: Baseline and 3 months
Change in Liver Enzymes
Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) measured from a fasting venipuncture sample as indicators of hepatic function.
Time frame: Baseline and 3 months
Change in Renal and Hepatic Markers
Serum total bilirubin and creatinine measured from a fasting venipuncture sample as indicators of hepatic and renal function.
Time frame: Baseline and 3 months
Change in Body Weight and Body Mass Index (BMI)
Body weight measured using a calibrated scale. BMI calculated from measured height and weight.
Time frame: Baseline and 3 months
Change in Body Composition
Lean mass and fat mass assessed via bioelectrical impedance analysis (BIA).
Time frame: Baseline and 3 months
Change in Resting Metabolic Rate
Resting metabolic rate measured using the MedGem indirect calorimetry device following standard protocol.
Time frame: Baseline and 3 months
Change in Appetite-Related Hormones
Serum concentrations of ghrelin, GLP-1, insulin, leptin, and peptide YY measured from fasting venipuncture samples.
Time frame: Baseline and 3 months
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Nov 2026, 22 months after the start.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 22 months is close to that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Semaglutide · Tirzepatide
Texas Tech University