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

Improving Neuropathy and Mobility in Subjects With Early Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Physical Activity
• Intervention / Treatment: Behavioral: Tailored Diet and Physical Activity; Behavioral: Standard of Care

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
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
    • Baltimore, Maryland, United States, 20742
      • University of Maryland
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • VA Ann Arbor Healthcare System, Ann Arbor, MI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Tailored Diet and Physical Activity; Subjects will receive an individually tailored diet and physical activity enhancement program	Behavioral: Tailored Diet and Physical Activity; Subjects will receive an individually tailored diet and physical activity enhancement program
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six Minute Walk (6MW) Test	Measures distance covered by participant when walking at a brisk pace without running for six minutes in feet.	Six Months
Change in 6-Minute-Walk Test Measured in Feet Between Baseline and 12 Months		Baseline and 12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraepidermal Nerve Fiber Density (Distal Leg)	Measure of the number of skin fibers/mm in the lower extremity (distal leg) at 12 months	12 Months
Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh	Measure of the number of skin fibers/mm in the lower extremity (proximal thigh) at 12 months	12 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical Activity (PA) at 12 Months as Measured by the CHAMPS (Community Health Activities Model Program for Seniors) Activity Scale	Physical Activity measured by CHAMPS provides an estimated caloric expenditure of subject based on weight and weekly physical activity, as assessed by the questionnaire. Change in physical activity is determined by the difference in daily caloric expenditure at baseline and 12 months.	Baseline and 12 Months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: University of Michigan; University of Maryland, College Park
• Investigators: Principal Investigator: James W Russell, MD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2009
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): February 8, 2018

Study Registration Dates

• First Submitted: October 24, 2008
• First Submitted That Met QC Criteria: October 24, 2008
• First Posted (Estimate): October 27, 2008

Study Record Updates

• Last Update Posted (Actual): April 9, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: diabetes; Neuropathy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: B6017-R; INMED 42940 (Other Identifier: UMMS IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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