Weight Gain and Adipose Tissue

This study aims to examine the role of weight gain in adipose tissue immune cell influx and development of obesity related cardiometabolic disorders. Adipose tissue-mediated chronic systemic inflammation is implicated in the development of cardiometabolic disorders in obesity. Therefore, resolution of adipose tissue inflammation may be key to ameliorating obesity-associated dyslipidemia, insulin-resistance, and cardiovascular disease. Proinflammatory cytokines contribute to the initial influx of immune cells into adipose tissue during weight gain. However, mechanisms regulating these cytokines in the adipose tissue milieu and the effects of weight gain on adipose tissue are not completely understood.

The study proposes to investigate the molecular events contributing to increased infiltration of macrophages and T-cells into adipose tissue during weight gain. The central hypothesis is that in lean subjects (with low body fat mass), healthy fat gain which is associated with decreased expression of proinflammatory cytokines. However, in obesity (high body fat mass), adipose tissue is altered, which permits increased expression of inflammatory cytokines and further fat gain results in influx of immune cells. To test the hypothesis, adipose tissue from well characterized lean (control, with low body fat) and obese individuals (with high body fat) at baseline and after a modest 5% weight gain will be used. Adipose tissue samples after subsequent weight loss will also be examined.

For this study, obesity will be defined by body composition rather than body mass index (BMI), as several studies have shown that BMI does not adequately define obesity and several individuals with normal BMI may indeed have high body fat mass. Individuals with body fat content ≤25% for men, & <35% for women) will be considered lean and individuals with body fat content >25% for men, ≥35% for women will be considered obese.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic, Rochester, Minnesota, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age: 18 to 40 (inclusive) years
BMI 18.5 <30 kg/m2
Gender: Both males and females will be allowed to participate in the study
Predominantly sedentary
Absence of any chronic medical conditions other than seasonal or environmental allergies
On no prescription medications other than second generation antihistamines (cetirizine , Fexofenadine, Desloratadine, Loratadine, etc), oral contraceptive pills, or intrauterine devices
Not a current smoker or tobacco user
Not pregnant or breast feeding and not intending to become pregnant or breast feed
Lean (low body fat mass) (body fat content ≤ 25% for men, < 35% for women) n=7; Obese (high body fat mass) (body fat content >25% for men, ≥ 35% for women) n=7
Ability to provide written informed consent

Exclusion criteria

Vulnerable study population will be excluded
Presence of chronic diseases such as diabetes, and cardiovascular disease
Pregnancy
Anemic (hemoglobin <13.5 g/dL for men and <12.0 g/dL for women)
Postmenopausal
Smoking
Use of chronic Medications (aspirin, statin, anti-inflammatory drugs)
Subjects found to have significant sleep disorders will be excluded
Dietary restrictions including lactose intolerance, and vegan diet
Eating disorders that may interfere with weight gain and weight loss

Treatment and study plan

overfeeding induced weight gain

Behavioral

Primary outcomes

Change from baseline in adipose tissue inflammation by 8 week of modest weight gain followed by 8 week of weight loss.

Time frame: 16-20 weeks

Adipose tissue inflammation will be measures by RTPCR and Western Blot. These will be presented as ratio to endogenous house keeping gene.

Secondary outcomes

Change from baseline in blood pressure by 8 week of modest weight gain followed by 8 weeks of weight loss.

Time frame: 16-20 weeks

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Pilot Study to Examine the Effects of Weight Gain on Adipose Tissue

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Mar 9, 2016
Registry last updated: Jan 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed