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Tirzepatide for Reversing Lipotoxicity and Adipose Tissue Dysfunction in Overweight/Obesity

This study is investigating how tirzepatide, a medication, might help people who are overweight or have obesity by improving how their fat cells (adipocytes) work. Researchers want to see if tirzepatide can reverse problems with fat storage and distribution, which are linked to health issues like high blood pressure and type 2 diabetes. The study will measure changes in fat cell size, fat storage capacity, and body fat distribution. You might be able to join if you are between 18 and 70 years old, are not diabetic, and have a BMI between 27 and 39.9 kg/m2. If your BMI is 27-29.9 kg/m2, you'll need to have at least one weight-related health factor like high blood pressure. The study is currently recruiting 66 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment (tirzepatide or diet). It plans to enroll 66 participants, but the phase and status are not specified.
What's involved
You would visit Stanford University for tests at baseline, week 6, and week 22. These visits include blood tests, body scans (DXA and MRI), and a fat tissue biopsy. You will also meet with a dietitian and coordinator every two weeks.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be measured at baseline, week 6, and week 22, which is the end of the study.

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NCT05912621

Tirzepatide: Reversal of Lipotoxicity and Adipose Tissue Dysfunction in Humans With Overweight/Obesity

Recruiting
PHASE2Ages 18–70InterventionalTreatment
Stanford University
~66 participants
Updated 2024-12-04 on ClinicalTrials.gov
What's tested:Tirzepatide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Adipocyte Size
Measured over Baseline and Week 22
+3 more outcomes measured

Conditions

Obesity
Overweight and Obesity
Overweight

Explore related trials

ObesityOverweight

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Tracey McLaughlin, MD · PRINCIPAL_INVESTIGATOR · Stanford School of Medicine

Who to contact

Nicole Turk, BS
[email protected]
6508880144
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

nondiabetic as defined by fasting plasma glucose \< 126 mg/dL while off all glucose lowering medications
BMI 27-39.9 kg/m2. Individuals with obesity (BMI 30-39.9 kg/m2) are not required to have an additional risk factor but those who are overweight (27-29.9 kg/m2) must have at least one weight-related factor as follows: hypertension defined as physician-diagnosed and taking antihypertensive medication or SBP\> 130 or DBP \> 80 mm Hg; dyslipidemia defined as physician diagnosed and taking medication or LDL \> 160 mg/dL, TG \> 150 mg/dL, HDL \< 50 or \< 40 mg/dL for women and men, respectively; prediabetes defined as fasting glucose 100-125 mg/dL off all antidiabetic or diabetogenic medications, physician diagnosed obstructive sleep apnea, non-alcoholic fatty liver disease, history of gallstones, and osteoarthritis.
Age 18-70
Pre and postmenopausal women will be eligible and details of last menstrual period and/or hormone replacement collected for statistical adjustment and formal testing for effect modification.

Exclusion

prior bariatric surgery or liposuction
unstable body weight defined as self-reported weight change \>2 kg over the past 6 weeks
unstable hypertension (defined as BP \>160/100 mm Hg)
major organ disease
chronic inflammatory conditions
pregnancy/lactation
active malignancy undergoing treatment
use (current or within the past three months) of diabetogenic or weight loss medications, including GLP1 analogs
active eating or psychiatric disorder
heavy alcohol use (\>2 drinks/day for women and \> 3 drinks/day for men) will be excluded

What this trial measures

  • Change in Adipocyte SizeBaseline and Week 22

    Using a multisizer, we will identify the size and distribution changes of fat cells from baseline to the end of the weight loss period to compare between tirzepatide administration and dietary restriction group

  • Change in Adipocyte Fat Storage CapacityBaseline and Week 22

    Using a Oil Red O and rtPCR, we will identify the fat storage capacity of fat cells from baseline to the end of the weight loss period to compare between tirzepatide administration and dietary restriction group

  • Assess changes in Regional FatBaseline, week 6, and week 22

    Using a DXA scan, we will measure the percentages of total, upper, lower, truncal, peripheral, and subcutaneous fat and compare it at baseline, 6 weeks, and 22 weeks for each participant

  • Change from baseline on the 2-stage Steady State Plasma Glucose testBaseline, week 6, and week 22

    Compare direct measurement of insulin sensitivity after baseline, week 6, and week 22