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Improving Neuropathy and Mobility in People With Early Diabetes (INMED)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Department of Veterans Affairs
Sponsor:
Collaborators:
University of Maryland
University of Michigan
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00780559
First received: October 24, 2008
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to determine if an individually tailored diet and physical enhancement program can improve mobility, physical activity, and neuropathy in people with early diabetes.


Condition Intervention Phase
Diabetes
Physical Activity
Behavioral: Tailored Diet and Physical Activity
Behavioral: Standard of Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Improving Neuropathy and Mobility in Subjects With Early Diabetes

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • six minute walk test [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • physical activity (6 months) and intraepidermal nerve fiber density (12 months) [ Time Frame: six to 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 142
Study Start Date: November 2009
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Tailored Diet and Physical Activity
Behavioral: Tailored Diet and Physical Activity
Subjects will receive an individually tailored diet and physical activity enhancement program
Arm 2
Standard of Care
Behavioral: Standard of Care
Subjects will be told to reduce their baseline weight by 7% and exercise for 150 minutes/week. There is no tailored, directed program.

Detailed Description:

Neuropathy is the most common complication of diabetes mellitus. Impaired glucose regulation (IGR) is associated with development of peripheral neuropathy coupled with gait and mobility impairment that may be disabling for the patient. Recent novel data from our group indicates that improved diet and exercise can significantly improve and even reverse neuropathy associated with IGR, however this has not been tested as a specific intervention in a controlled diabetes complications trial. IGR includes patients with early type 2 diabetes mellitus (T2DM), impaired glucose tolerance (IGT), and impaired fasting glucose (IFG) based on standardized criteria for the diagnosis of T2DM. We hypothesize that, compared to IGR participants advised to follow the current standard care recommendations on diet and exercise (Standard Care or "SC"), IGR participants undergoing a Tailored Diet and Physical Activity (TDPA) enhancement program will show greater improvement in the 6 minute walk test (6MW) and will show a greater reduction in markers of neuropathy progression e.g. intraepidermal nerve fiber density IEFND. Furthermore, we will test the hypothesis that improvement in measures of neuropathy, mobility function and physical activity (PA) will correlate strongly with each other and with improvement in specific measures of metabolic function, and weight loss. This proposal will permit us to determine if TDPA can improve mobility and induce nerve regeneration in subjects with early diabetes.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • IGR at the time of screening or within three months of screening. This definition includes patients with impaired fasting glucose (IFG), impaired glucose tolerance (IGT), and early diabetes. Patients can be included if they have an increased risk for diabetes with a HBA1C > or = 5.7% (using a method certified by the National Glycohemoglobin Standardization Program), or they have diabetes with a HBA1C > or equal to 6.5%, or an abnormal fasting venous glucose, or abnormal venous glucose values following a 75 gram oral load. Glucose values are as defined (mg/dl): IFG fasting greater than 100 mg/dl, IGT- fasting less than 126, 2 h 140-199, or diabetes - fasting glucose > 126, 2 h > 200 based on the Standards for Medical Care in Diabetes 2010 by the American Diabetes Association.
  • The HbA1c may be normal, but must be <8%.
  • If diabetic subjects are on medication, they should be stable on medication for at least 3 months prior to entering the study. Addition or change in antidiabetic medications after enrollment does not affect participation or group assignment.
  • No risk factors for other causes for neuropathy (determined by a medical history, family history, history of medications, occupational history, history of exposure to toxins, physical and neurological examinations, and laboratory studies).
  • Clinical signs or symptoms of neuropathy as determined by the treating neurologists history and physical exam, PLUS an abnormality of one of the following: NCS, QSART, QST, or IENFD.
  • Age range from 30 to 80 years inclusive at the time of screening
  • Medically stable at the time of enrollment.
  • Able to participate in a standing exercise program without constant standby monitoring.
  • Women of childbearing potential must be using an acceptable method of contraception to prevent pregnancy when they are enrolled in the study and must agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.
  • Patient must agree to taking an alternative medication to coumadin when undergoing a skin biopsy
  • Willing to complete weekly self-report questionnaires.
  • Willing to accept assignment to either training group.
  • Willing and able to increase activity level and exercise independently at home.

Exclusion Criteria:

Number Criteria

  • Pregnant women, prisoners, institutionalized subjects and other at risk subjects will not be included in this study.
  • Taking insulin.
  • Etiology of sensorimotor neuropathy other than IGR based on careful clinical and laboratory evaluation.
  • Current severe medical conditions that are active on the day of enrollment and would affect a patient's ability to complete study. This may include active advanced current ischemic heart disease (e.g., angina or congestive heart failure), permanent residual lower extremity weakness or loss of balance resulting from a stroke, active severe obstructive or restrictive pulmonary disease, ongoing cancer treatment, renal failure currently requiring dialysis, or severe ongoing peripheral vascular disease.
  • An inability to understand or cooperate with the procedures of the trial or refusal to sign the informed consent.
  • Patients who are unable to answer questions correctly on the Evaluation to Sign Consent (ESC) tool.
  • Significant other neurologic, rheumatological, neuromuscular, or other extremity conditions that limit safe exercise or weight bearing.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780559

Contacts
Contact: Christopher Bever, MD (410) 605-7130 christopher.bever@va.gov
Contact: Lindsay A Zilliox, MD (410) 328-3100 lzilliox@som.umaryland.edu

Locations
United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Recruiting
Baltimore, Maryland, United States, 21201
Contact: Rizamarie Empeno, BS    410-328-3100    rempeno@som.umaryaryland.edu   
Contact: Lindsay A Zilliox, MD    (410) 328-3100    lzilliox@som.umaryland.edu   
Principal Investigator: James W Russell, MD         
University of Maryland Recruiting
Baltimore, Maryland, United States, 20742
Contact: Ankit Sura, MBBS    410-328-3100    ASura@som.umaryland.edu   
United States, Michigan
VA Ann Arbor Healthcare System Recruiting
Ann Arbor, Michigan, United States, 48113
Contact: Debra M Strasburg    734-763-8970    Debra.Strasburg@va.gov   
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Debra M Strasburg    734-763-8970    dstrasbu@umich.edu   
Sponsors and Collaborators
University of Maryland
University of Michigan
Investigators
Principal Investigator: James W Russell, MD VA Maryland Health Care System, Baltimore
  More Information

Additional Information:
Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00780559     History of Changes
Other Study ID Numbers: B6017-R, INMED 42940
Study First Received: October 24, 2008
Last Updated: May 9, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Neuropathy
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 22, 2014