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

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 14-002163
    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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Michael Jensen, M.D.

Open for enrollment

Contact information:

Pamela Reich

(507)255-6062

Reich.Pamela@mayo.edu

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CLS-20151354

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