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

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ClinicalTrials.gov Identifier: NCT02689661
Recruitment Status : Active, not recruiting
First Posted : February 24, 2016
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Brian Callaghan, University of Michigan

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

Condition or disease
Metabolic Syndrome Obesity Neuropathy

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.


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Study Type : Observational
Actual Enrollment : 177 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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.
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.



Primary Outcome Measures :
  1. 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)

  2. Nerve fiber density at the leg [ Time Frame: Change from baseline to year 2 ]

Secondary Outcome Measures :
  1. Sural sensory nerve conduction amplitude [ Time Frame: Baseline and 2 year ]
    Physiologic parameter

  2. Peroneal motor nerve conduction amplitude [ Time Frame: Baseline and 2 year ]
    Physiologic parameter

  3. Tibial motor nerve conduction amplitude [ Time Frame: Baseline and 2 year ]
    Physiologic parameter


Biospecimen Retention:   Samples Without DNA
Plasma or serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will include eligible patients who are currently enrolled in the University of Michigan Investigational Weight Management Clinic as well as age and gender matched lean controls.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689661


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-2200
Sponsors and Collaborators
Brian Callaghan
Investigators
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Principal Investigator: Brian C Callaghan, MD, MS University of Michigan
  Study Documents (Full-Text)

Documents provided by Brian Callaghan, University of Michigan:
Informed Consent Form  [PDF] November 8, 2018


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brian Callaghan, Assistant Professor of Neurology, University of Michigan
ClinicalTrials.gov Identifier: NCT02689661     History of Changes
Other Study ID Numbers: NINDS-NS079417
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases