A Study of the Effects of Inflammation on Fat Tissue and Insulin in People with Different Body Shapes


Sponsor Protocol Number: 14-002163

About this study

The purpose of this study is to see why the ability of fat cells to respond to insulin is different depending on body shape and how fat tissue inflammation is involved.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Adult men and women over 18 – 55 years of age.
  • Obese participants with BMI of 27-37 kg/m2, type 2 DM participants with BMI 20-40 kg/m2 and non-obese participants with BMI <27kg/m2 who meet the predefined criteria for UBO, LBO, T2DM and non-obese.
  • Women should be premenopausal and men should be age matched to the premenopausal women of the same group.
  • Participants should be healthy enough to undergo the testing procedures and participate in a weight loss program.
  • For non-obese Alkaline Phosphatase, CBC, Electrolyte Panel, G.O. Transaminase (serum), Glucose and Lipid Profiles will all need values in the normal range. For obese and overweight participants only the CBC and electrolyte panel must be in the normal range; transaminase, glucose and lipid values are anticipated to be abnormal to a modest degree in obesity.
  • For Type II Diabetic volunteers they will need a HbA1C between 7.0% and 9.5%. As with obese participants (above), transaminase, glucose and lipid values are anticipated to be abnormal to a modest degree in many patients.
  • Participants should be able to give appropriate informed consent to participate in the study.
  • Participants should be weight stable for 2 months before the start of the study.

Exclusion Criteria


  • History of ischemic heart disease, atherosclerotic vascular disease or known systemic inflammatory (infectious, autoimmune) illness.
  • Blood pressure greater than 160/95 despite antihypertensive medication.
  • Use of medications known to affect free fatty acid (FFA) or adipose tissue metabolism, including, but not limited to, beta blockers, niacin and pioglitazone.
  • Pregnant women, prisoners or other special vulnerable category of participants.

More information


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