Exercise-facilitated Neurorehabilitation in Diabetic Neuropathy
20. september 2019 opdateret af: VA Office of Research and Development
Exercise-Facilitated NeuroRehabilitation in Diabetic Neuropathy
This study will determine the type and combination of exercise needed to rehabilitate the neuro-compromised diabetic Veteran.
Guided exercise protocols may prove to be practical therapeutic options for the prophylactic management of diabetic subjects with neuropathy.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Purpose: A single-site, randomized, blinded, prospective clinical trial is proposed to determine the significance of a combined isokinetic strength and aerobic exercise training program on the rehabilitation of peripheral nerve function in Type 2 diabetic veterans and non-veterans with neuropathy.
Background and Significance: Obesity is a major factor in the increasing rates of diabetes and its related complications.
Diabetes affects greater than 7% of the population.
Veterans are at even greater risk, with approximately 16% currently receiving treatment at Department of Veterans Affairs Medical Centers for diabetes.
More than half of affected veterans experience debilitating complications of diabetes, including peripheral neuropathy (PN).
Exercise training, in combination with pharmacologic intervention, is now recognized as a cornerstone of management for diabetes.
Therapeutic interventions currently available for the treatment of PN in diabetic patients are limited, however, to pain management and stringent glycemic control.
Exercise is reported to significantly decrease peripheral nerve microvascular complications common among chronic diabetics.
Our preliminary findings demonstrate that exercise intervention improves peripheral nerve function in the diabetic veteran with PN.
Intervention strategies, such as proposed in this application, offer a unique and novel therapeutic option for the rehabilitation of the neuro-compromised Type 2 diabetic veterans and non-veterans.
Methods & Research Plan: One-hundred subjects will be recruited for this 24-week study.
Subjects each will be randomly assigned to aerobic, isokinetic strength training, combined aerobic and strength training, or non-exercise (control) intervention groups.
Isokinetic strength training (Biodex System 3), aerobic exercise training (treadmill), or the combination of strength and aerobic training will be administered 3x per week for the initial 12 weeks.
Control subjects will receive 12 clinical visits over the course of the initial 12 weeks.
The effects of exercise training type, compared with control subjects, on recovery of peripheral nerve function will be rigorously determined from baseline, 12- and 24-week testing using electrodiagnostic primary outcome measures, Quantitative Sensory Testing, and a battery of validated qualitative and quantitative secondary outcome measures that include an incremental symptom-limited treadmill test, peak torque, Total Neuropathy Score, visual analogue pain scale, and quality of life SF-36V Health Survey.
Sustainability of effect will be determined at 24-weeks.The individual effects of exercise training type, compared with control subjects, on tissue oxygenation will be determined from baseline, 12- and 24-week testing by non-invasive quantitated infrared spectroscopy using an InSpectraTM Tissue Spectrometer.
Expected Outcomes: This study will objectively and critically determine the type and combination of exercise needed to rehabilitate the neuro-compromised diabetic Veteran.
Guided exercise protocols may prove to be practical therapeutic options for the prophylactic management of diabetic subjects with neuropathy.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
45
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Illinois
-
Hines, Illinois, Forenede Stater, 60141-5000
- Edward Hines Jr. VA Hospital, Hines, IL
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
45 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Clinical diagnosis of type 2 diabetes mellitus
- stable blood glucose control
- clinical findings consistent with length-dependent sensorimotor polyneuropathy, stage N2a
Exclusion Criteria:
- foot ulceration
- unstable heart disease
- co-morbid conditions limiting exercise
- disorders of the central nervous system causing weakness or sensory loss
- received treatment with medications known to have neuropathy as a prominent side effect including vincristine, vinblastine, cis-platin, and paclitaxel
- medical conditions that may be associated with neuropathies such as alcoholism, liver disease, kidney disease, toxic exposure, vitamin deficiency, autoimmune disorders, cancer, or hypothyroidism
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Arm 1
Sedentary Control Group
|
|
|
Eksperimentel: Arm 2
Aerobic Exercise Group
|
Structured aerobic exercise (treadmill).
Structured isokinetic strength exercise (dynameter).
|
|
Eksperimentel: Arm 3
Isokinetic Strength Exercise Group
|
Structured aerobic exercise (treadmill).
Structured isokinetic strength exercise (dynameter).
|
|
Eksperimentel: Arm 4
Combined Aerobic and Isokinetic Strength Exercise Group
|
Structured aerobic exercise (treadmill).
Structured isokinetic strength exercise (dynameter).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Sural Nerve Amplitude
Tidsramme: Baseline, 12, and 24 weeks
|
Maximal responses were obtained using percutaneous electrical stimuli.
Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities.
A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies.
The patients dominant side was chosen.
In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen.
In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
|
Baseline, 12, and 24 weeks
|
|
Sural Nerve Latency
Tidsramme: Baseline, 12 wks, 24 wks
|
Maximal responses were obtained using percutaneous electrical stimuli.
Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities.
A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies.
The patients dominant side was chosen.
In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen.
In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
|
Baseline, 12 wks, 24 wks
|
|
Sural Nerve Conduction Velocity
Tidsramme: Baseline, 12 wks, 24 wks
|
Maximal responses were obtained using percutaneous electrical stimuli.
Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities.
A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies.
The patients dominant side was chosen.
In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen.
In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
|
Baseline, 12 wks, 24 wks
|
|
Tibial Nerve Amplitude
Tidsramme: Baseline, 12 weeks, 24 weeks
|
Maximal responses were obtained using percutaneous electrical stimuli.
Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities.
A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies.
The patients dominant side was chosen.
In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen.
In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
|
Baseline, 12 weeks, 24 weeks
|
|
Tibial Nerve Latency
Tidsramme: Baseline, 12 weeks, 24 weeks
|
Maximal responses were obtained using percutaneous electrical stimuli.
Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities.
A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies.
The patients dominant side was chosen.
In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen.
In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
|
Baseline, 12 weeks, 24 weeks
|
|
Tibial Nerve Conduction Velocity
Tidsramme: Baseline, 12 weeks, 24 weeks
|
Maximal responses were obtained using percutaneous electrical stimuli.
Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities.
A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies.
The patients dominant side was chosen.
In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen.
In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
|
Baseline, 12 weeks, 24 weeks
|
|
Sensory Median Nerve Amplitude
Tidsramme: Baseline, 12, and 24 weeks
|
Maximal responses were obtained using percutaneous electrical stimuli.
Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities.
A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies.
The patients dominant side was chosen.
In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen.
In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
|
Baseline, 12, and 24 weeks
|
|
Sensory Median Nerve Latency
Tidsramme: Baseline, 12wks, 24 wks
|
Maximal responses were obtained using percutaneous electrical stimuli.
Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities.
A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies.
The patients dominant side was chosen.
In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen.
In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
|
Baseline, 12wks, 24 wks
|
|
Sensory Median Nerve Conduction Velocity
Tidsramme: Baseline, 12 wks, 24 wks
|
Maximal responses were obtained using percutaneous electrical stimuli.
Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities.
A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies.
The patients dominant side was chosen.
In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen.
In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
|
Baseline, 12 wks, 24 wks
|
|
Sensory Ulnar Nerve Amplitude
Tidsramme: Baseline, 12 wks, 24 wks
|
Maximal responses were obtained using percutaneous electrical stimuli.
Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities.
A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies.
The patients dominant side was chosen.
In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen.
In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
|
Baseline, 12 wks, 24 wks
|
|
Sensory Ulnar Nerve Latency
Tidsramme: Baseline, 12 wks, 24 wks
|
Maximal responses were obtained using percutaneous electrical stimuli.
Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities.
A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies.
The patients dominant side was chosen.
In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen.
In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
|
Baseline, 12 wks, 24 wks
|
|
Sensory Ulnar Nerve Conduction Velocity
Tidsramme: Baseline, 12 wks, 24 wks
|
Maximal responses were obtained using percutaneous electrical stimuli.
Sensory nerve action potentials were recorded from sural (antidromic), median (antidromic to second digit), and ulnar nerves (antidromic to fifth digit).To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities.
A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies.
The patients dominant side was chosen.
In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen.
In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
|
Baseline, 12 wks, 24 wks
|
|
Peroneal Nerve Amplitude
Tidsramme: Baseline, 12 wks, 24 wks
|
Maximal responses were obtained using percutaneous electrical stimuli.
Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities.
A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies.
The patients dominant side was chosen.
In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen.
In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
|
Baseline, 12 wks, 24 wks
|
|
Peroneal Nerve Latency
Tidsramme: Baseline, 12 wks, 24 wks
|
Maximal responses were obtained using percutaneous electrical stimuli.
Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities.
A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies.
The patients dominant side was chosen.
In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen.
In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
|
Baseline, 12 wks, 24 wks
|
|
Peroneal Nerve Conduction Velocity
Tidsramme: Baseline, 12 wks, 24 wks
|
Maximal responses were obtained using percutaneous electrical stimuli.
Distal motor nerve evoked compound muscle action potential (CMAP) potentials were recorded from tibial and peroneal nerves.To minimize inter-examiner variability and maximize neurophysiologic test/retest reliability, the same experienced neurologist conducted all nerve conduction studies on days separate from all other testing activities.
A dedicated TECA Synergy electromyograph system was used for all nerve conduction studies.
The patients dominant side was chosen.
In patients with definable differences between the two sides, the side with the most prominent clinical findings was chosen.
In all cases, the same limb was used for all three (baseline, 12-weeks, 24-weeks) conduction studies.
|
Baseline, 12 wks, 24 wks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Symptom-Limited TMT Blood Glucose Response
Tidsramme: Initial entry into study, 12 and 24 weeks
|
Changes in blood glucose in response to modified Bruce Protocol treadmill test (TMT)
|
Initial entry into study, 12 and 24 weeks
|
|
Short Form-36V: Physical Component Score
Tidsramme: Initial entry into study, 12 and 24 weeks
|
The short form-36Veterans (SF-36V) health survey questionnaire was used to measure health-related quality of life.
This survey is comprised of eight subscales and two overall component scores, all of which have demonstrated high levels of internal consistency and discriminate validity when administered to groups of medically stable individuals.
Patient aggregate responses for the eight distinct summary subscales and two component scores were compiled as a percentage of total points possible using the RAND 36-item health survey table.
Data shown are expressed as a percentage of total possible score ranging from 0%-100% with 100% considered relatively good health and 0% considered poor health.
Physical Component scores reflect perceived changes in physical health relative to the previous year.
|
Initial entry into study, 12 and 24 weeks
|
|
Voluntary Duration of Symptom-Limited TMT
Tidsramme: baseline, 12-wks, 24-wks
|
Total time subjects voluntarily exercised while undergoing a modified Bruce Protocol treadmill test (TMT)
|
baseline, 12-wks, 24-wks
|
|
Symptom-Limited TMT Maximum Heart Rate
Tidsramme: baseline, 12-wks, 24-wks
|
Peak heart rate achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
|
baseline, 12-wks, 24-wks
|
|
Symptom-Limited TMT Maximum Systolic Blood Pressure
Tidsramme: Baseline, 12-wk, 24-wk
|
Peak systolic BP achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
|
Baseline, 12-wk, 24-wk
|
|
Symptom-Limited TMT Maximum Minute Ventilation (VE)
Tidsramme: Baseline, 12-wks, 24-wks
|
Peak volume of air exchanged per minute achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
|
Baseline, 12-wks, 24-wks
|
|
Symptom-Limited TMT Maximum Oxygen Uptake (VO2)
Tidsramme: Baseline, 12-wks, 24-wks
|
Peak Oxygen uptake achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
|
Baseline, 12-wks, 24-wks
|
|
Maximum Respiratory Exchange Ratio (RER) During TMT
Tidsramme: Baseline, 12-wks, 24-wks
|
Peak RER achieved while undergoing a modified Bruce Protocol treadmill test (TMT).
This is a mathematical ratio of maximally achieved (peak) VCO2 divided by maximally achieved (peak) VO2.
|
Baseline, 12-wks, 24-wks
|
|
Symptom-Limited TMT Maximum Carbon Dioxide Expelled (VCO2)
Tidsramme: Baseline, 12-wks, 24-wks
|
Peak Carbon Dioxide expelled achieved while undergoing a modified Bruce Protocol treadmill test (TMT)
|
Baseline, 12-wks, 24-wks
|
|
Symptom-Limited TMT Maximum METS Achieved (MET)
Tidsramme: Baseline, 12-wks, 24-wks
|
Peak metabolic rate equivalents (METS) achieved while undergoing a modified Bruce Protocol treadmill test (TMT).
One MET is defined as the metabolic rate observed at rest, quantified as resting oxygen consumption of 250 ml/min (Male) or 200 ml /min (female).
A value of 5 METS would represent a metabolic rate that is 5x that at rest and is considered an indicator of how hard a given individual is exercising.
Data shown are expressed as a ratio at peak of exercise of oxygen consumed relative to normalized values for men or women at rest.
|
Baseline, 12-wks, 24-wks
|
|
Short Form-36V: Mental Component Score
Tidsramme: initial entry into study, and at 12-wks and 24-wks
|
The short form-36Veterans (SF-36V) health survey questionnaire was used to measure health-related quality of life.
This survey is comprised of eight subscales and two overall component scores, all of which have demonstrated high levels of internal consistency and discriminate validity when administered to groups of medically stable individuals.
Patient aggregate responses for the eight distinct summary subscales and two component scores were compiled as a percentage of total points possible using the RAND 36-item health survey table.
Data shown are expressed as a percentage of total possible score ranging from 0%-100% with 100% considered relatively good health and 0% considered poor health.
Mental Component scores reflect perceived changes in emotional health relative to the previous year.
|
initial entry into study, and at 12-wks and 24-wks
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Height
Tidsramme: baseline
|
Height of subjects upon entry into study
|
baseline
|
|
Weight
Tidsramme: Baseline, 12-wks, 24-wks
|
Weight of subjects at baseline, 12-weeks, and 24-weeks
|
Baseline, 12-wks, 24-wks
|
|
Body Mass Index (BMI)
Tidsramme: Baseline, 12-wk, 24-wk
|
BMI is calculated as a ratio of subject body mass (kg) divided by the square of subject height (m).
|
Baseline, 12-wk, 24-wk
|
|
Duration of Diabetes Mellitus
Tidsramme: Baseline
|
Duration, in years, since first diagnosed with Diabetes Mellitus upon entry into study
|
Baseline
|
|
HbA1C Laboratory Values
Tidsramme: Baseline, 12-wk, 24-wk
|
Laboratory values of subject HbA1C levels at Baseline, 12-wk, 24-wk
|
Baseline, 12-wk, 24-wk
|
|
Triglyceride Laboratory Values
Tidsramme: Baseline
|
Laboratory triglyceride values at baseline entry into study
|
Baseline
|
|
Cholesterol Laboratory Values
Tidsramme: Baseline
|
Laboratory total cholesterol, HDL-cholesterol, and LDL-cholesterol levels at baseline entry into study
|
Baseline
|
|
Creatinine Laboratory Values
Tidsramme: Baseline
|
Laboratory creatinine values at baseline entry into study
|
Baseline
|
|
Blood Urea Nitrogen (BUN) Laboratory Values
Tidsramme: Baseline
|
Laboratory Blood Urea Nitrogen levels at baseline entry into study
|
Baseline
|
|
Aspartate Aminotransferase Laboratory Values
Tidsramme: Baseline
|
Laboratory values for Aspartate Aminotransferase (AST) at baseline entry into study
|
Baseline
|
|
Thyroid Stimulating Hormone Laboratory Values
Tidsramme: Baseline
|
Laboratory values for Thyroid Stimulating Hormone (TSH) at baseline entry into study
|
Baseline
|
|
Age
Tidsramme: at baseline
|
Age of participants at entry into study.
|
at baseline
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Evan Stubbs, Edward Hines Jr. VA Hospital, Hines, IL
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
14. januar 2010
Primær færdiggørelse (Faktiske)
14. november 2014
Studieafslutning (Faktiske)
14. november 2014
Datoer for studieregistrering
Først indsendt
6. august 2009
Først indsendt, der opfyldte QC-kriterier
7. august 2009
Først opslået (Skøn)
10. august 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. oktober 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. september 2019
Sidst verificeret
1. september 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B6954-R
- I01RX000130 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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