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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00780559
Recruitment Status : Completed
First Posted : October 27, 2008
Last Update Posted : March 16, 2018
University of Maryland
University of Michigan
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Physical Activity Behavioral: Tailored Diet and Physical Activity Behavioral: Standard of Care Phase 2

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 the investigators' 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. The investigators 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, the investigators 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Improving Neuropathy and Mobility in Subjects With Early Diabetes
Actual Study Start Date : November 1, 2009
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : February 8, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. six minute walk test [ Time Frame: six month ]
    measure distance covered in 6 minutes

Secondary Outcome Measures :
  1. intraepidermal nerve fiber density (12 months) and physical activity [ Time Frame: six to 12 months ]
    measure the number of skin fibers/mm in the lower extremity

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.

Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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: nerve conduction studies (NCS), Quantitative Sudomotor Autonomic Reflex Testing (QSART), Quantitative Sensory Testing (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:

  • 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.

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 identifier (NCT number): NCT00780559

United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 20742
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
VA Office of Research and Development
University of Maryland
University of Michigan
Principal Investigator: James W Russell, MD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Publications of Results:
Responsible Party: VA Office of Research and Development Identifier: NCT00780559     History of Changes
Other Study ID Numbers: B6017-R
INMED 42940 ( Other Identifier: UMMS IRB )
First Posted: October 27, 2008    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:

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