Improving Neuropathy and Mobility in People With Early Diabetes

NCT00780559 | Completed Results

• 2 other identifiers: B6017-RINMED 42940
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes; Physical Activity

Keywords

Neuropathy; diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Intraepidermal Nerve Fiber Density (Distal Leg)

  12 Months

• Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh

  12 Months

Other Outcomes (1)

• Change in Physical Activity (PA) at 12 Months as Measured by the CHAMPS (Community Health Activities Model Program for Seniors) Activity Scale

  Baseline and 12 Months

Study Arms (2)

Tailored Diet and Physical Activity

OTHER

Subjects will receive an individually tailored diet and physical activity enhancement program

Behavioral: Tailored Diet and Physical Activity

Standard of Care

OTHER

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

Interventions

Tailored Diet and Physical Activity BEHAVIORAL

Subjects will receive an individually tailored diet and physical activity enhancement program

Tailored Diet and Physical Activity

Standard of Care BEHAVIORAL

Subjects will be told to reduce their baseline weight by 7% and exercise for 150 minutes/week. There is no tailored, directed program.

Standard of Care

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Maryland, College Park: collaborator
• University of Michigan: collaborator

Study Sites (3)

University of Maryland

Baltimore, Maryland, 20742, United States

Location

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Motor Activity

Interventions

Exercise; Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Clinical Research Coordinator
• Organization: University of Maryland School of Medicine

inmed@som.umaryland.edu

(410) 328-6583

Study Officials

• James W Russell, MD

  Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: parallel treatments

Study Record Dates

• First Submitted: October 24, 2008
• First Posted: October 27, 2008
• Study Start: November 1, 2009
• Primary Completion: December 31, 2017
• Study Completion: February 8, 2018
• Last Updated: April 9, 2021
• Results First Posted: September 9, 2019

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)