Improving Neuropathy and Mobility in People With Early Diabetes (INMED)
2021年3月16日 更新者:VA Office of Research and Development
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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
72
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Maryland
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Baltimore、Maryland、アメリカ、21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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Baltimore、Maryland、アメリカ、20742
- University of Maryland
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Michigan
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Ann Arbor、Michigan、アメリカ、48105
- VA Ann Arbor Healthcare System, Ann Arbor, MI
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
30年~80年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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他の:Tailored Diet and Physical Activity
Subjects will receive an individually tailored diet and physical activity enhancement program
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Subjects will receive an individually tailored diet and physical activity enhancement program
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他の: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.
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Subjects will be told to reduce their baseline weight by 7% and exercise for 150 minutes/week.
There is no tailored, directed program.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Six Minute Walk (6MW) Test
時間枠:Six Months
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Measures distance covered by participant when walking at a brisk pace without running for six minutes in feet.
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Six Months
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Change in 6-Minute-Walk Test Measured in Feet Between Baseline and 12 Months
時間枠:Baseline and 12 Months
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Baseline and 12 Months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Intraepidermal Nerve Fiber Density (Distal Leg)
時間枠:12 Months
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Measure of the number of skin fibers/mm in the lower extremity (distal leg) at 12 months
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12 Months
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Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh
時間枠:12 Months
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Measure of the number of skin fibers/mm in the lower extremity (proximal thigh) at 12 months
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12 Months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change in Physical Activity (PA) at 12 Months as Measured by the CHAMPS (Community Health Activities Model Program for Seniors) Activity Scale
時間枠:Baseline and 12 Months
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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.
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Baseline and 12 Months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者:James W Russell, MD、Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2009年11月1日
一次修了 (実際)
2017年12月31日
研究の完了 (実際)
2018年2月8日
試験登録日
最初に提出
2008年10月24日
QC基準を満たした最初の提出物
2008年10月24日
最初の投稿 (見積もり)
2008年10月27日
学習記録の更新
投稿された最後の更新 (実際)
2021年4月9日
QC基準を満たした最後の更新が送信されました
2021年3月16日
最終確認日
2021年3月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Tailored Diet and Physical Activityの臨床試験
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University of OttawaThe Ottawa Hospital; Queen's University; Consortium of Multiple Sclerosis Centers完了
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Centre Hospitalier Universitaire de Besancon募集