- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02689661
Impact of the Metabolic Syndrome on the Incidence of Neuropathy in Obese Subjects
The Impact of the Metabolic Syndrome on the Incidence of Neuropathy in Obese Subjects
Study Overview
Status
Conditions
Detailed Description
The investigators propose to follow obese individuals and determine the impact of the aspects of the metabolic syndrome on the incidence of neuropathy compared to lean individuals.
While there are many well established relationships between obesity and disease, the association of obesity and the metabolic syndrome with peripheral neuropathy is less clear.
The investigators will be following a population of 300 adult individuals age 18 years or older with obesity and 300 adult individuals without obesity or any aspect of the metabolic syndrome (hyperlipidemia, hypertriglyceridemia, hypertension, hyperglycemia, obesity). Obese subjects will be recruited through the Investigational Weight Management Clinic. A proportion of the subjects will be recruited through Blue Care Network of Michigan (BCN) as part of their Healthy Blue Living campaign which is supporting clinical care of up to 400 individuals in the clinic. The individuals not recruited directly through the clinic will be identified via flyer, word of mouth, and umclinicalstudies.org.
The phenotyping information for the obese subjects will be already completed as part of the initial project. Lean subjects will undergo screening for eligibility, which includes taking height, weight, blood pressure, lipid profile, and glucose tolerance test.
Neuropathy measures completed at baseline and 2 years (obese subjects only) include: definite clinical neuropathy will be established using Toronto consensus guidelines based upon neurologic exam, nerve conduction studies, Michigan Neuropathy-Specific Instrument, Utah Early Neuropathy Scale, balance and hip strength measures, cognitive testing (computerized cognitive screening to determine how obesity affects the central nervous system) (also done at time 12 +/- 4 weeks and 52 +/- 4 weeks post-baseline visit), neurothesiometer testing, skin biopsy to determine nerve fiber density, Quantitative Sudomotor Axon Reflex Test (QSART) to measures the autonomic nerves that control sweating, heart rate variability/cardiac autonomic neuropathy testing to assess for autonomic neuropathy, quantitative sensory testing to assess for small fiber neuropathy, Sudoscan to assess sweat gland function, and the following questionnaires: Neuropathy Quality of Life, McGill Pain, Autonomic symptoms profile.
The investigators intend to demonstrate that obesity and other aspects of the metabolic syndrome have a direct impact on the incidence of peripheral neuropathy.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109-2200
- University of Michigan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age over 18
- Willing and able to provide written informed consent, enrolled in the Investigational Weight Management Clinic at the University of Michigan
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Obese participants
Obese participants recruited from the University of Michigan Investigational Weight Management Clinic.
Subjects in this group complete the five surveys, undergo extensive metabolic phenotyping, and a comprehensive neuropathy assessment at study entry and again at 2 years.
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Lean participants
Healthy lean age and gender matched controls recruited via the umclinicaltrials.org
complete the five surveys, complete an oral glucose tolerance test and cholesterol panel, as well as the complete comprehensive neuropathy assessment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurologist history and examination for presence of neuropathic symptoms, abnormal sensory examination findings, and abnormal reflexes (no specific instrument)
Time Frame: Baseline
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Toronto definition of probable clinical neuropathy (2 or 3 out of 3 of the following: neuropathic symptoms, sensory examination findings, and reflexes)
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Baseline
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Nerve fiber density at the leg
Time Frame: Change from baseline to year 2
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Change from baseline to year 2
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sural sensory nerve conduction amplitude
Time Frame: Baseline and 2 year
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Physiologic parameter
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Baseline and 2 year
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Peroneal motor nerve conduction amplitude
Time Frame: Baseline and 2 year
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Physiologic parameter
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Baseline and 2 year
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Tibial motor nerve conduction amplitude
Time Frame: Baseline and 2 year
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Physiologic parameter
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Baseline and 2 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brian C Callaghan, MD, MS, University of Michigan
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NINDS-NS079417
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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