Impact of the Metabolic Syndrome on the Incidence of Neuropathy in Obese Subjects

Completed

Conditions studied: Metabolic Syndrome, Obesity, Neuropathy

In brief

The primary purpose of this study is to discover modifiable risk factors for the development of neuropathy, specifically looking at the metabolic syndrome.

Key facts

Study ID

NCT02689661

Run by

Brian Callaghan

People needed

177

Starts

2010-11-01

Expected to finish

2019-12-31

Last updated by the study team

2020-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age over 18
• Willing and able to provide written informed consent, enrolled in the Investigational Weight Management Clinic at the University of Michigan

You may not qualify if…

• Taking blood thinning medications, except aspirin, Evidence of inherited disorders of lipid metabolism
• History of cancer within the last 5 years
• Human immunodeficiency virus (HIV) antibody positive
• Subjects with solid organ transplants
• Participation in any other clinical trial within 90 days of entry into this trial
• Pregnant or lactating females
• Uncontrolled thyroid disease
• Unstable angina or New York heart association class II failure or above
• Gastrointestinal disease specifically gastrointestinal motility disorders
• Unstable neuropsychiatric disease including major depression/anxiety, bulimia, or anorexia
• End stage renal or hepatic disease
• Autoimmune disorders (e.g. lupus)
• Body weight fluctuation of more than 5 kg in the previous 3 months
• Prior bariatric surgery
• A history or current substance abuse, change in smoking habits, or cessation in the past 6 months
• Women of childbearing age must use a reliable form of contraception
• Any medical condition, which would make the patient unsuitable for recruitment, or could interfere with the patient participating in or completing the protocol

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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