Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT05165706

Recruiting nowNot applicableInterventional

What this study is about

This 12-week controlled diet and weight intervention study seeks to define the molecular pathways that link excess body weight to the development of insulin resistance (IR). Blood, adipose and stool are sampled at three timepoints; baseline, peak weight (4 weeks) and post weight loss to monitor changes in cellular processes. Additionally, direct insulin sensitivity testing, and radiological measurement of visceral fat and intrahepatic fat content is measured at three timepoints to correlate clinical indices with cellular changes.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age35 Years to 65 Years

SexAll

Healthy volunteersAccepted

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

Full registry criteria

Inclusion Criteria: * Age 35-65 * BMI 25-35 kg/m2 * Stable body weight * Nondiabetic Exclusion Criteria: Patients with; * 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 Clinical screening exclusions; * hematocrit \< 33% * fasting glucose \>/= 126 mg/dL * blood pressure \>160/100 mmHg

Treatments and study arms

Dietary Intervention Mediterranean Low Carbohydrate Diet

Behavioral

Assigned participants will receive instruction by a registered dietitian on a diet that is high in unsaturated fats and low in carbohydrates. Total caloric intake will be adjusted to induce a supervised metabolic challenge defined as weight gain of approximately 2.5 kg over 5 weeks followed by 3-5kg weight loss over 8 weeks.

Dietary Intervention Standard Low Carbohydrate Diet

Behavioral

Assigned participants will receive instruction by a registered dietitian on a low carbohydrate diet that is high in fats found in the typical American diet. Total caloric intake will be adjusted to induce a supervised metabolic challenge defined as weight gain of approximately 2.5 kg over 5 weeks followed by 3-5kg weight loss over 8 weeks.

Dietary Intervention Standard Low Fat Diet

Behavioral

Assigned participants will receive instruction by a registered dietitian on a low fat diet that is high in complex carbohydrates. Total caloric intake will be adjusted to induce a supervised metabolic challenge defined as weight gain of approximately 2.5 kg over 5 weeks followed by 3-5kg weight loss over 8 weeks.

Primary outcomes

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.

Study locations

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Stanford University🇺🇸 Stanford, California, United States

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Ekrem M Ayhan, BSContact

Email · Call 908-619-5381

Dalia Perelman, MS, RDContact

Tracey L McLaughlin, MD, MSPrincipal Investigator