Clinical trial NCT01184170: Metabolically Normal and Metabolically Abnormal Obesity
Official title: Metabolically Normal and Metabolically Abnormal Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Metabolic Syndrome
Keywords: obesity
metabolism
cardiovascular metabolic syndrome
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2010-08-18
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to learn more about why some obese persons are resistant to developing obesity-related metabolic diseases (such as diabetes and cardiovascular disease), while others are prone to developing these conditions. We will do this by studying obese persons before and after a 5% body weight gain.

Subjects will be asked to increase their current diet for a period of 8-12 weeks in order to increase their current body weight by 5%. Each will then be asked to maintain this weight increase for 3 weeks. We will monitor subjects throughout this time period with weekly medical evaluations. At the completion of the study, we will provide each subject with a 6-month weight loss program.


Eligibility criteria: Inclusion Criteria:

* Obese subjects (BMI 30.0 - 39.9 kg/m2)
* Sedentary subjects (exercise less than 1 hr/wk)

Exclusion Criteria:

* Pregnant or lactating women
* Michigan Alcohol Screening Test score ≥4
* Active or previous history of liver disease
* Active or previous history of diabetes
* history of alcohol abuse, or currently consuming ≥20 g alcohol/day
* Severe hypertriglyceridemia (\>300 mg/dL)
* Smoke tobacco
* Take medication that might confound the study results

Primary outcomes:
measure: Change in Intrahepatic Triglyceride
timeFrame: an average of three months, from baseline to 5% weight gain
measure: Change in de novo lipogenesis
timeFrame: an average of three months, from baseline to 5% weight gain
measure: Change in VLDL kinetics
timeFrame: an average of three months, from baseline to 5% weight gain
measure: Change in hepatic insulin sensitivity
timeFrame: an average of three months, from baseline to 5% weight gain
measure: Change in skeletal muscle insulin sensitivity
timeFrame: an average of three months, from baseline to 5% weight gain
Secondary outcomes:
measure: Change in adipose tissue insulin sensitivity
timeFrame: an average of three months, from baseline to 5% weight gain
measure: Change in CD36 concentration in skeletal muscle
timeFrame: an average of three months, from baseline to 5% weight gain
measure: change in CD36 concentration in adipose tissue
timeFrame: an average of three months, from baseline to 5% weight gain
measure: Change in cell proliferation (growth) rates in the colon
timeFrame: an average of three months, from baseline to 5% weight gain
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Samuel Klein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yoshino J, Patterson BW, Klein S. Adipose Tissue CTGF Expression is Associated with Adiposity and Insulin Resistance in Humans. Obesity (Silver Spring). 2019 Jun;27(6):957-962. doi: 10.1002/oby.22463. Epub 2019 Apr 19.
citation: Fabbrini E, Tiemann Luecking C, Love-Gregory L, Okunade AL, Yoshino M, Fraterrigo G, Patterson BW, Klein S. Physiological Mechanisms of Weight Gain-Induced Steatosis in People With Obesity. Gastroenterology. 2016 Jan;150(1):79-81.e2. doi: 10.1053/j.gastro.2015.09.003. Epub 2015 Sep 12.
citation: Fabbrini E, Yoshino J, Yoshino M, Magkos F, Tiemann Luecking C, Samovski D, Fraterrigo G, Okunade AL, Patterson BW, Klein S. Metabolically normal obese people are protected from adverse effects following weight gain. J Clin Invest. 2015 Feb;125(2):787-95. doi: 10.1172/JCI78425. Epub 2015 Jan 2.