Impact of the Metabolic Syndrome on the Incidence of Neuropathy in Obese Subjects
|ClinicalTrials.gov Identifier: NCT02689661|
Recruitment Status : Active, not recruiting
First Posted : February 24, 2016
Last Update Posted : August 7, 2019
|Condition or disease|
|Metabolic Syndrome Obesity Neuropathy|
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 :||Observational|
|Actual Enrollment :||177 participants|
|Official Title:||The Impact of the Metabolic Syndrome on the Incidence of Neuropathy in Obese Subjects|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||December 31, 2019|
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.
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.
- Neurologist history and examination for presence of neuropathic symptoms, abnormal sensory examination findings, and abnormal reflexes (no specific instrument) [ Time Frame: Baseline ]Toronto definition of probable clinical neuropathy (2 or 3 out of 3 of the following: neuropathic symptoms, sensory examination findings, and reflexes)
- Nerve fiber density at the leg [ Time Frame: Change from baseline to year 2 ]
- Sural sensory nerve conduction amplitude [ Time Frame: Baseline and 2 year ]Physiologic parameter
- Peroneal motor nerve conduction amplitude [ Time Frame: Baseline and 2 year ]Physiologic parameter
- Tibial motor nerve conduction amplitude [ Time Frame: Baseline and 2 year ]Physiologic parameter
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689661
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109-2200|
|Principal Investigator:||Brian C Callaghan, MD, MS||University of Michigan|