Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05165706
Other study ID # 40195
Secondary ID 5R01DK110186-02
Status Recruiting
Phase N/A
First received
Last updated
Start date January 31, 2019
Est. completion date December 30, 2024

Study information

Verified date April 2023
Source Stanford University
Contact Ekrem M Ayhan, BS
Phone 908-619-5381
Email ayhane@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date December 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 65 Years
Eligibility 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

Study Design


Intervention

Behavioral:
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.
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.
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.

Locations

Country Name City State
United States Stanford University Stanford California

Sponsors (2)

Lead Sponsor Collaborator
Stanford University National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline on the 2-stage Steady State Plasma Glucose test Compare direct measurement of insulin sensitivity after 4 week diet and weight intervention Peak weight (4 weeks)
Primary Change from baseline on the radiographic measurement of visceral to subcutaneous (V:S) fat ratio Compare measurement of abdominal V:S fat volume via computed tomography (CT) after 4 week diet and weight intervention Peak weight (4 weeks)
Primary Change from baseline on the magnetic-resonance based measurement of intrahepatic lipid deposition Compare measurement of liver fat content via magnetic resonance spectroscopy (MRS) after 4 week diet and weight intervention Peak weight (4 weeks)
Primary Change from peak weight on the 2-stage Steady State Plasma Glucose test Compare direct measurement of insulin sensitivity after 8 week diet and weight intervention Post-weight loss (8 weeks)
Primary Change from baseline on the radiographic measurement of visceral to subcutaneous (V:S) fat ratio Compare measurement of abdominal V:S fat volume via computed tomography (CT) after 8 week diet and weight intervention Post-weight loss (8 weeks)
Primary Change from baseline on the magnetic-resonance based measurement of intrahepatic lipid deposition Compare measurement of liver fat content via magnetic resonance spectroscopy (MRS) after 8 week diet and weight intervention Post-weight loss (8 weeks)
Primary Measurement of markers of lipid and carbohydrate metabolism and inflammation from adipose mRNA Compare adipose tissue transcripts such as known MODY transcription factors, defensin chemokine receptors, and platelet activation factors measured by PCR between participants identified as Insulin sensitive (IS) and Insulin resistant (IR) using the 2-stage Steady State Plasma Glucose test. Baseline
Primary Quantification of plasma inflammatory cytokine levels in serum samples by Luminex immunoassay Compare plasma inflammatory cytokine levels in serum samples as measured by Luminex immunoassay between participants identified as Insulin Sensitive (IS) and Insulin Resistant (IR) using the 2-stage Steady State Plasma Glucose test. Baseline
Primary Change from baseline in plasma inflammatory cytokine levels in serum samples as measured by Luminex immunoassay Compare intra-personal levels of plasma inflammatory cytokines as measured by Luminex immunoassay after 4 week diet and weight intervention Peak Weight (4 weeks)
See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2