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Dietary Interventions for Insulin Resistance
N/A
Recruiting
Led By Tracey McLaughlin, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 35-65
Nondiabetic
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-weight loss (8 weeks)
Awards & highlights
Study Summary
This trial aims to understand how loss of excess weight can help reduce risk of developing insulin resistance. Blood, fat and stool are monitored to measure cellular changes.
Who is the study for?
This trial is for adults aged 35-65 with a BMI of 25-35 who have maintained a stable weight and are not diabetic. It's not suitable for those with eating disorders, psychiatric conditions, high blood pressure, diabetes, history of certain weight loss surgeries, heavy alcohol use, recent significant weight change or major organ disease.Check my eligibility
What is being tested?
The study tests how different diets (Mediterranean Low Carbohydrate Diet vs Standard Low Carbohydrate Diet vs Standard Low Fat Diet) affect the body's response to insulin over a period of 12 weeks. Participants will undergo diet interventions and regular monitoring including blood tests and radiological assessments.See study design
What are the potential side effects?
While this trial focuses on dietary interventions which typically don't have severe side effects like drugs do, participants may experience changes in digestion or energy levels due to new diets. Individual responses to diet changes vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 35 and 65 years old.
Select...
I do not have diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-weight loss (8 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-weight loss (8 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in plasma inflammatory cytokine levels in serum samples as measured by Luminex immunoassay
Change from baseline on the 2-stage Steady State Plasma Glucose test
Change from baseline on the magnetic-resonance based measurement of intrahepatic lipid deposition
+4 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Standard Low Carbohydrate DietExperimental Treatment1 Intervention
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 II: Mediterranean Low Carbohydrate DietExperimental Treatment1 Intervention
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 III: Low Fat, Healthy Carbohydrate DietExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,370 Previous Clinical Trials
4,315,512 Total Patients Enrolled
88 Trials studying Insulin Resistance
13,243 Patients Enrolled for Insulin Resistance
Stanford UniversityLead Sponsor
2,401 Previous Clinical Trials
17,341,759 Total Patients Enrolled
30 Trials studying Insulin Resistance
2,360 Patients Enrolled for Insulin Resistance
Tracey McLaughlin, MDPrincipal InvestigatorStanford University, Department of Medicine, Division of Endocrinology
8 Previous Clinical Trials
419 Total Patients Enrolled
4 Trials studying Insulin Resistance
228 Patients Enrolled for Insulin Resistance
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood pressure is higher than 160/100 mmHg.Your body mass index (BMI) is between 25 and 35.I have a serious condition affecting a major organ.My weight has changed in the last 3 months.I am between 35 and 65 years old.Your hematocrit level is less than 33%.I do not have diabetes.I have had liposuction or bariatric surgery in the past.Your weight has stayed about the same.Your fasting blood sugar level is 126 mg/dL or higher.I have diabetes.You drink a lot of alcohol.You have an eating disorder or a mental health condition that is currently affecting you.I am currently taking medication for weight loss, statins, or oral steroids.
Research Study Groups:
This trial has the following groups:- Group 1: Low Fat, Healthy Carbohydrate Diet
- Group 2: Mediterranean Low Carbohydrate Diet
- Group 3: Standard Low Carbohydrate Diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
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