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

NCT ID: NCT05165706

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-31

Study Completion Date

2026-12-30

Brief Summary

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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.

Detailed Description

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Obesity has become an epidemic worldwide. Metabolic/cardiovascular complications of obesity are likely related to the fact that obese individuals tend to be insulin resistant (IR). While insulin- mediated glucose uptake (IMGU) correlates with adipose tissue mass, not all obese individuals are IR, and metabolic and cardiovascular profiles of those who are IR vs insulin sensitive (IS) differ significantly. Why one individual who reaches a BMI of 30 kg/m2 will develop IR and another with similar BMI and activity level remains IS is unclear. Furthermore, while insulin sensitivity improves with weight loss, this response varies as well. Given that fat mass per se does not fully explain the obesity contribution to IMGU, itis likely that differential adipocyte function plays a role. With this study, our purpose is to employ an integrated omics strategy to identify analyte/pathway signatures in blood and adipose tissue that characterize IR versus IS states and expand our biological knowledge of the mechanisms underlying IR.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Mediterranean Low Carbohydrate Diet

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.

Group Type EXPERIMENTAL

Dietary Intervention Mediterranean Low Carbohydrate Diet

Intervention Type 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.

Standard Low Carbohydrate Diet

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.

Group Type EXPERIMENTAL

Dietary Intervention Standard Low Carbohydrate Diet

Intervention Type 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.

Low Fat, Healthy Carbohydrate Diet

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.

Group Type EXPERIMENTAL

Dietary Intervention Standard Low Fat Diet

Intervention Type 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.

Interventions

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Dietary Intervention Mediterranean Low Carbohydrate Diet

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.

Intervention Type BEHAVIORAL

Dietary Intervention Standard Low Carbohydrate Diet

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.

Intervention Type BEHAVIORAL

Dietary Intervention Standard Low Fat Diet

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Tracey McLaughlin

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tracey McLaughlin, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University, Department of Medicine, Division of Endocrinology

Locations

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Stanford University

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ekrem M Ayhan, BS

Role: CONTACT

[email protected]
908-619-5381

Dalia Perelman, MS, RD

Role: CONTACT

[email protected]

Facility Contacts

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Ekrem M Ayhan, BS

Role: primary

[email protected]
908-619-5381

Dalia Perelman, MS, RD

Role: backup

[email protected]

Other Identifiers

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5R01DK110186-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

40195

Identifier Type: -

Identifier Source: org_study_id