Longitudinal Multi-Omic Profiles to Reveal Mechanisms of Obesity-Mediated Insulin Resistance
Recruiting · Stanford, California
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Your choice
Voluntary — you can stop anytime
What is this study?
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.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
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.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Age 35 to 65.
- •BMI 25 to 35 kg/m².
- •Stable body weight (no recent big weight changes).
- •Does NOT have diabetes.
- •Can have screening blood pressure under 160/100 mmHg and fasting glucose below 126 mg/dL.
🚫 You may not be able to join if…
- •Have diabetes.
- •Have major organ disease.
- •Had liposuction or bariatric surgery.
- •Have an active eating disorder or psychiatric disorder.
- •Are pregnant or breastfeeding (or currently using weight loss meds, statins, or oral steroids).
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults age 35 to 65
- ✓BMI between 25 and 35 kg/m²
- ✓Generally stable body weight and not diabetic
- ✓Not currently pregnant or breastfeeding
- ✓Without major exclusions like diabetes, bariatric/liposuction history, or active eating/psychiatric disorders
- !Not for people who are pregnant or breastfeeding
How this study is designed
The real details, in plain words. Tap the underlined words to learn what they mean.
- ✓Everyone in this study receives an active treatment — there is no placebo group.
- •You'd be placed into a group by chance, like a coin flip — this keeps the study fair.
- •There are 3 groups in this study.
What to expect, step by step
· This study lasts about 4 weeks- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
About 4 weeksIf you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
What's being tested
- Behavioral: Dietary Intervention Mediterranean Low Carbohydrate Diet
- Behavioral: Dietary Intervention Standard Low Carbohydrate Diet
- Behavioral: Dietary Intervention Standard Low Fat Diet
Has this treatment been tested before?
The study team can share what safety testing has been done so far.
Who's running this study?
Sponsor
Stanford University
Overseen by Tracey McLaughlin, MD
Every study is also reviewed by an independent that protects participants.
What you need to know before you apply
What is this study testing?+
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.
Is it safe? Who makes sure of that?+
This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT05165706 · Locations: California