Metabolic SyndromeNCT02689661
Impact of the Metabolic Syndrome on the Incidence of Neuropathy in Obese Subjects
An observational study of Metabolic Syndrome and Obesity, run by Brian Callaghan at 1 site in United States.
Trial summary
The primary purpose of this study is to discover modifiable risk factors for the development of neuropathy, specifically looking at the metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obesity, Neuropathy
- Type of treatment
- Pill or oral medicine
- How many people
- 177 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age over 18
- Willing and able to provide written informed consent, enrolled in the Investigational Weight Management Clinic at the University of Michigan
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan
Ann Arbor, Michigan, 48109-2200
About this study
Official title: The Impact of the Metabolic Syndrome on the Incidence of Neuropathy in Obese Subjects
The primary purpose of this study is to discover modifiable risk factors for the development of neuropathy, specifically looking at the metabolic syndrome.
Read the 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.
- Conditions
- Metabolic Syndrome, Obesity, Neuropathy
- Medical subject headings
- Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurologist history and examination for presence of neuropathic symptoms, abnormal sensory examination findings, and abnormal reflexes (no specific instrument)
Toronto definition of probable clinical neuropathy (2 or 3 out of 3 of the following: neuropathic symptoms, sensory examination findings, and reflexes)
Measured: Baseline
Nerve fiber density at the leg
Measured: Change from baseline to year 2
Secondary outcomes (3)
Sural sensory nerve conduction amplitude
Physiologic parameter
Measured: Baseline and 2 year
Peroneal motor nerve conduction amplitude
Physiologic parameter
Measured: Baseline and 2 year
Tibial motor nerve conduction amplitude
Physiologic parameter
Measured: Baseline and 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startNov 2010
- Primary completionJul 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brian Callaghan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brian Callaghan, University of Michigan
- Investigators
- Brian C Callaghan, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689661
- Sponsor's protocol ID
- NINDS-NS079417
- Status last verified
- Feb 2020
- First submitted
- 14 Jan 2016
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Callaghan BC, Xia R, Reynolds E, Banerjee M, Rothberg AE, Burant CF, Villegas-Umana E, Pop-Busui R, Feldman EL. Association Between Metabolic Syndrome Components and Polyneuropathy in an Obese Population. JAMA Neurol. 2016 Dec 1;73(12):1468-1476. doi: 10.1001/jamaneurol.2016.3745.
PubMed 27802497
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Metabolic Syndrome on the Incidence of Neuropathy in Obese Subjects
- ClinicalTrials.gov ID
- NCT02689661
- Acronym / sponsor ID
- NINDS-NS079417
- Conditions
- Metabolic Syndrome, Obesity, Neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Brian CallaghanUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jul 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to discover modifiable risk factors for the development of neuropathy, specifically looking at the metabolic syndrome.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age over 18
- Willing and able to provide written informed consent, enrolled in the Investigational Weight Management Clinic at the University of Michigan
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Sural sensory nerve conduction amplitude
Time frame: Baseline and 2 year
Peroneal motor nerve conduction amplitude
Time frame: Baseline and 2 year
Tibial motor nerve conduction amplitude
Time frame: Baseline and 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Derived from this study: PubMed 27802497Callaghan BC, Xia R, Reynolds E, Banerjee M, Rothberg AE, Burant CF, Villegas-Umana E, Pop-Busui R, Feldman EL. Association Between Metabolic Syndrome Components and Polyneuropathy in an Obese Population. JAMA Neurol. 2016 Dec 1;73(12):1468-1476. doi: 10.1001/jamaneurol.2016.3745.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian C Callaghan, MD, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome and Obesity, run by Brian Callaghan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurologist history and examination for presence of neuropathic symptoms, abnormal sensory examination findings, and abnormal reflexes (no specific instrument) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02689661, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.