Status:
ACTIVE_NOT_RECRUITING
Precision Nutrition and Metabolic Function
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Centene Corporation
Conditions:
Obesity
Insulin Resistance
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The purposes of this study are: 1) to determine the mechanisms responsible for the development of cardiometabolic complications in some, but not all people with obesity; 2) determine the best dietary ...
Detailed Description
Excess adiposity causes alterations in metabolic function including impaired glucose homeostasis and insulin resistance, which are important risk factors for type 2 diabetes (T2D) and cardiovascular d...
Eligibility Criteria
Inclusion
- Metabolically healthy lean subjects must have a body mass index (BMI) 18.5-24.9 kg/m2, intrahepatic triglyceride (IHTG) content ≤5%, serum triglyceride (TG) concentration \<150 mg/dl, fasting plasma glucose concentration \<100 mg/dl, 2-hr oral glucose tolerance test (OGTT) plasma glucose concentration ≤140 mg/dl, and hemoglobin A1C (HbA1C) ≤5.6%.
- Metabolically healthy obese subjects must have a BMI 30-49.9 kg/m2; IHTG content ≤5%, serum TG concentration \<150 mg/dl, fasting plasma glucose concentration \<100 mg/dl, 2-hr OGTT plasma glucose concentration ≤140 mg/dl, and HbA1C ≤5.6%.
- Metabolically unhealthy obese subjects must have a BMI 30-49.9 kg/m2; IHTG content ≥5.6% and fasting plasma glucose concentration ≥100 mg/dl or 2-hr OGTT plasma glucose concentration ≥140 mg/dl or HbA1C ≥5.7%.
Exclusion
- medical, surgical, or biological menopause;
- previous bariatric surgery where the gastrointestinal tract is reconstructed such as Roux-en-Y, sleeve gastrectomy and biliopancreatic diversion surgeries;
- laparoscopic adjustable gastric band (lab band) surgery within the last 3 years;
- structured exercise ≥250 min per week (e.g., brisk walking);
- unstable weight (\>4% change during the last 2 months before entering the study);
- significant organ system dysfunction (e.g., diabetes requiring medications, severe pulmonary, kidney or cardiovascular disease);
- cancer or cancer that has been in remission for \<5 years;
- polycystic ovary syndrome;
- major psychiatric illness;
- conditions that render subject unable to complete all testing procedures (e.g., severe ambulatory impairments, limb amputations, or metal implants that interfere with imaging procedures; coagulation disorders);
- severe anemia;
- regular use of tobacco products;
- excessive consumption of alcohol (≥3 drinks/day for men and ≥2 drinks/day for women);
- use of medications that are known to affect the study outcome measures (e.g., steroids, non-statin lipid-lowering medications) or increase the risk of study procedures (e.g., anticoagulants) and that cannot be temporarily discontinued for this study;
- use of antibiotics in last 60 days;
- pregnant or lactating women;
- vegans, vegetarians, those with lactose intolerance and/or severe aversions/sensitivities to eggs, fish, nuts, wheat and soy, and/or any individuals with food allergies that induce an anaphylactic response;
- persons who are not able to grant voluntary informed consent
Key Trial Info
Start Date :
October 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04131166
Start Date
October 8 2019
End Date
December 31 2029
Last Update
July 11 2025
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110