Rozlišení skupin pacientů pomocí autonomní dysfunkce
A study population with impaired fasting glucose levels, impaired glucose tolerance levels and diabetes (with or without complications) along with healthy patients will be chosen as participants. Their vital signs and their ECG (electrocardiograph) will be recorded during their only visit. Data analysis will be performed using the vital signs parameters. The RR intervals from the ECG will be analyzed by 5 different techniques to determine the best technique that stratifies the subjects the most accurately.
Přehled studie
Detailní popis
The Autonomic Nervous System (ANS) is a fundamental part of the nervous system in the body. And yet, there is no technique to test or measure the health and functioning of a person's autonomic nervous system.This type of study will determine the most accurate methodology to test the autonomic nervous system through heart rate variability (HRV) monitoring and gain vital information to distinguish patient groups in the diabetic population.
There is no gold standard for measuring autonomic dysfunction. Currently the method of power spectral analysis is finding very wide usage. It Is known that power spectral analysis does not discriminate the two subsystems of the ANS well. There are other beat to beat methodologies that have not yet gained traction. The reason for conducting this trial is to take a group of subjects in various stages of impaired fasting glucose, impaired glucose tolerance and diabetes (with and without complications) and determine which methodology stratifies these subjects most accurately.
Our study aims to introduce a new measurement method named the 'Beat to Beat' (BB) method for gauging autonomic dysfunction in patients. The investigators hope to observe that the average beat to beat method (BB) score could help discriminating diabetic patients into the following five distinct groups from the pilot study:
- Normal blood glucose level: - (A blood sugar level less than 140 mg/dL)
- Impaired fasting glucose (IFG): - (A fasting blood sugar level from 100 to 125 mg/dL)
- Impaired glucose tolerance (IGT): - (two-hour glucose levels of 140 to 199 mg per dL
- Diabetes without complications: - (e.g., no neuropathy, no retinopathy or nephropathy)
- Diabetes with complications: - (at least one complication among neuropathy, retinopathy, or nephropathy)
By showing that this measurement bears no relationship to the other four vital signs parameters (heart rate, blood oxygenation, blood pressure, body temperature), it will prove the necessity of this measurement in addition to the four vital signs for distinguishing patient groups among the diabetic population.
Typ studie
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Adults of either sex with various stages of impaired fasting glucose tolerance levels and diabetes (with or without complications) will be considered as study population.
Popis
Inclusion Criteria:
- Can provide informed consent.
- Age between 18 and 85 years old
- Body Mass Index: 25 ≤ BMI ≤ 40
- Hemoglobin A1c level: 7.5 ≤ HbA1c ≤ 9.5
- Individuals with pre-diabetes and diabetes Type II for at least 1 year (diagnosed by ADA criteria) and up to 20 years
- Advanced diabetic complications including neuropathy, nephropathy, retinopathy and other related complications
- Stable dose of medications for the previous 3 months
- Stable diet and lifestyle for the previous 3 months
- Stable medical status (Ex: no myocardial infarction, stroke, major surgery,
Exclusion Criteria:
- Unable to provide informed consent
- Chronic disease (e.g. HIV, Cushing syndrome, CKD, acromegaly, active hyperthyroidism etc.)
- Cancer and anticancer treatment in the last 5 years
- Psychiatric disorders (that in the eyes of the investigator should exclude the participant)
- Any disorder, which in the investigator's opinion might jeopardize subject's safety or compliance with the protocol
- Organ (kidney, pancreas, liver) transplant recipients
- Pregnancy or lactation
- Positive drug screen (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and alcohol)
- Alcoholics or Smokers
- Positive screen on HBsAg, anti-HCV or anti-HIV ½
- History of diabetic ketoacidosis or hyperosmolar coma
- Subjects with known coronary artery disease or coronary revascularisation
- Subjects with previous history of cerebrovascular accident
- Subjects with known proliferative retinopathy or previous laser treatment for diabetic retinopathy
- Subjects with life-threatening conditions including malignancy
- Subjects with known psychiatric conditions including depression
- Subjects with significant renal impairment (eGFR<60ml/min at baseline) or non-diabetic renal disease (e.g. biopsy-proven glomerulonephritis or obstructive uropathy)
- Subjects with major physical disability
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: CROSS_SECTIONAL
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Impaired Fasting Glucose Individuals
The group contains subjects with various stages of impaired fasting glucose tolerance levels and diabetes (with or without complications). All subjects will be considered in one group since the heart rate variability and vital signs are monitored in a single visit. |
Heart rate variability measurement and vital signs monitoring will be performed on all subjects. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Determination of autonomic dysfunction by subject
Časové okno: The measurement will happen in a single visit i.e 1 day.
|
The ANSiScope Plus will be used to determine the BB (beat to beat) score through heart rate variability measurements. |
The measurement will happen in a single visit i.e 1 day.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Establish the absence of any relationship of autonomic dysfunction (AD) to any other vital signs parameters.
Časové okno: The measurement will happen in a single visit i.e 1 day.
|
Investigate the importance of measuring the autonomic dysfunction in the presence of other vital signs measurements (heart rate, body temperature, blood oxygenation and blood pressure) |
The measurement will happen in a single visit i.e 1 day.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Dr. Bathula Sridhar, MD,DM (Endo), Samraksha Diabetes, Thyroid, Endocrine Superspecialty Hospital and Research Centre
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CS011
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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