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Dietary Interventions for Obesity-Mediated Insulin Resistance

This study is looking into how different diets affect insulin resistance (when your body's cells don't respond well to insulin, a hormone that helps sugar get into cells). Researchers want to understand why some people with obesity develop insulin resistance and others don't. You would be assigned to one of three dietary interventions: a Mediterranean Low Carbohydrate Diet, a Standard Low Carbohydrate Diet, or a Standard Low Fat Diet. The study will measure changes in your insulin sensitivity, body fat, and liver fat over 12 weeks. They are looking for participants aged 35-65 who are overweight (BMI 25-35 kg/m2) and do not have diabetes. The study aims to enroll 110 people, but its current recruitment status is unclear.

Study design
This is an interventional study with an estimated enrollment of 110 participants, comparing three different dietary interventions.
What's involved
You would receive dietary instruction from a registered dietitian and your caloric intake would be adjusted to induce a supervised weight gain of approximately 2 units. Blood, fat tissue, and stool samples would be collected at three timepoints: at the start, at 4 weeks (peak weight), and after weight loss. Direct insulin sensitivity testing and radiological measurements of fat would also be done at these three timepoints.
Compensation
Not stated in the trial record.
Follow-up
Measurements are taken at baseline, 4 weeks (peak weight), and post weight loss, indicating a follow-up period of at least 4 weeks and beyond.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05165706

Longitudinal Multi-Omic Profiles to Reveal Mechanisms of Obesity-Mediated Insulin Resistance

Recruiting
NAAges 35–65InterventionalPrevention
Stanford University
~110 participants
Updated 2024-12-04 on ClinicalTrials.gov
What's tested:Dietary Intervention Mediterranean Low Carbohydrate DietDietary Intervention Standard Low Carbohydrate DietDietary Intervention Standard Low Fat Diet

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 from baseline on the 2-stage Steady State Plasma Glucose test
Measured over Peak weight (4 weeks)
+8 more outcomes measured

Conditions

Diabetes Mellitus, Type 2
PreDiabetes
Insulin Resistance
Obesity
Nonalcoholic Steatohepatitis
Nonalcoholic Fatty Liver
Diet Modification

Explore related trials

Insulin ResistanceNonalcoholic Fatty Liver DiseaseNonalcoholic SteatohepatitisObesity

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Tracey McLaughlin, MD · PRINCIPAL_INVESTIGATOR · Stanford University, Department of Medicine, Division of Endocrinology

Who to contact

Ekrem M Ayhan, BS
[email protected]
908-619-5381
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 35-65
BMI 25-35 kg/m2
Stable body weight
Nondiabetic

Exclusion

diabetes
major organ disease
history of liposuction or bariatric surgery
active eating or psychiatric disorder
pregnancy or lactation, heavy alcohol use
recent change in weight (over the past 12 weeks)
use of weight loss medication, statins, or oral steroids
hematocrit \< 33%
fasting glucose \>/= 126 mg/dL
blood pressure \>160/100 mmHg

What this trial measures

  • Change from baseline on the 2-stage Steady State Plasma Glucose testPeak weight (4 weeks)

    Compare direct measurement of insulin sensitivity after 4 week diet and weight intervention

  • Change from baseline on the radiographic measurement of visceral to subcutaneous (V:S) fat ratioPeak weight (4 weeks)

    Compare measurement of abdominal V:S fat volume via computed tomography (CT) after 4 week diet and weight intervention

  • Change from baseline on the magnetic-resonance based measurement of intrahepatic lipid depositionPeak weight (4 weeks)

    Compare measurement of liver fat content via magnetic resonance spectroscopy (MRS) after 4 week diet and weight intervention

  • Change from peak weight on the 2-stage Steady State Plasma Glucose testPost-weight loss (8 weeks)

    Compare direct measurement of insulin sensitivity after 8 week diet and weight intervention

  • Change from baseline on the radiographic measurement of visceral to subcutaneous (V:S) fat ratioPost-weight loss (8 weeks)

    Compare measurement of abdominal V:S fat volume via computed tomography (CT) after 8 week diet and weight intervention

  • Change from baseline on the magnetic-resonance based measurement of intrahepatic lipid depositionPost-weight loss (8 weeks)

    Compare measurement of liver fat content via magnetic resonance spectroscopy (MRS) after 8 week diet and weight intervention

  • Measurement of markers of lipid and carbohydrate metabolism and inflammation from adipose mRNABaseline

    Compare adipose tissue transcripts such as known MODY transcription factors, defensin chemokine receptors, and platelet activation factors measured by PCR between participants identified as Insulin sensitive (IS) and Insulin resistant (IR) using the 2-stage Steady State Plasma Glucose test.

  • Quantification of plasma inflammatory cytokine levels in serum samples by Luminex immunoassayBaseline

    Compare plasma inflammatory cytokine levels in serum samples as measured by Luminex immunoassay between participants identified as Insulin Sensitive (IS) and Insulin Resistant (IR) using the 2-stage Steady State Plasma Glucose test.

  • Change from baseline in plasma inflammatory cytokine levels in serum samples as measured by Luminex immunoassayPeak Weight (4 weeks)

    Compare intra-personal levels of plasma inflammatory cytokines as measured by Luminex immunoassay after 4 week diet and weight intervention