Weight Gain and Adipose Tissue

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02703766
• Other study ID #: 15-007623
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 2018

Study information

• Verified date: January 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Gain

Intervention

Behavioral:
• overfeeding induced weight gain

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in adipose tissue inflammation by 8 week of modest weight gain followed by 8 week of weight loss.	Adipose tissue inflammation will be measures by RTPCR and Western Blot. These will be presented as ratio to endogenous house keeping gene.	16-20 weeks
Secondary	Change from baseline in blood pressure by 8 week of modest weight gain followed by 8 weeks of weight loss.		16-20 weeks