NCT05165706 Longitudinal Multi-Omic Profiles to Reveal Mechanisms of Obesity-Mediated Insulin Resistance
| NCT ID | NCT05165706 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2019-01-31 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2019-01-31 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Tracey McLaughlin, MD
PRINCIPAL INVESTIGATOR
Stanford University, Department of Medicine, Division of Endocrinology
Frequently Asked Questions
Who can join the NCT05165706 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 65 Years, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05165706 currently recruiting?
Yes, NCT05165706 is actively recruiting participants. Contact the research team at ayhane@stanford.edu for enrollment information.
Where is the NCT05165706 trial being conducted?
This trial is being conducted at Stanford, United States.
Who is sponsoring the NCT05165706 clinical trial?
NCT05165706 is sponsored by Stanford University. The principal investigator is Tracey McLaughlin, MD at Stanford University, Department of Medicine, Division of Endocrinology. The trial plans to enroll 110 participants.
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