- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01660009
Adverse Effects of Systemic Hypoglycemia Exposure on Endothelial Function in Humans
10. august 2017 opdateret af: Medical College of Wisconsin
Prior work suggests exposure to low glucose levels (hypoglycemia) is associated with increased cardiovascular risk.
However, whether there is a causal relationship between cardiovascular events and hypoglycemia remains unclear with conflicting data in the literature.
In this study, we plan to study whether acute exposure of patients to clinically relevant (50-60 milligrams/deciliter) levels of hypoglycemia induces or worsens blood vessel endothelial dysfunction- a key 1st step in the development of heart attacks and strokes.
This will be determined in humans both with and with type 2 diabetes.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
5
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Wisconsin
-
Milwaukee, Wisconsin, Forenede Stater, 53226
- Medical College of Wisconsin
-
-
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
21 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Type 2 Diabetes Inclusion Criteria
- Adult age 21 or older
- If on 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase reductase therapy, must be on a stable dose for at least 6 weeks prior to enrollment
- Diagnosis of type 2 diabetes by a physician as defined by the American Diabetes Association standard criteria: 1) Fasting Plasma glucose at or above 126 mg/dL 2) a two-hour value in an oral glucose tolerance test at or above 200 mg/dL, or 3) a random plasma glucose concentration 200 mg/dL in the presence of symptoms, or 4) glycosylated hemoglobin greater than or equal to 6.5%.
Score of < 4 using the Gold method for assessing hypoglycemia awareness
Inclusion Criteria for Healthy subjects
- Adult age 21 or older
- No evidence of metabolic syndrome or diabetes, hypertension (BP≥140/90), or high cholesterol (LDL≥160) at the time of screen.
Exclusion Criteria:
- History of stroke, peripheral arterial disease, or coronary artery disease (as defined by the presence of at least one coronary stenosis ≥ 40% on angiography or by confirmed history of myocardial infarction by standard criteria)
- Evidence of other evident major illness including chronic renal insufficiency(plasma creatinine > 1.4 for women or 1.5 for men), liver disease (aspartate aminotransferase or alanine aminotransferase greater than 2.5 x normal), and cancer currently undergoing therapy or had therapy for cancer within 1 year of enrollment.
- Pregnancy as determine by urinary pregnancy test
- Subjects on warfarin, oral anti-thrombin inhibitors, or thienopyridines
- Subjects who have had changes to dosing of thiazolidinedione, dipeptidyl peptidase-4 (DPP-4) inhibitor, or metformin therapy within 6 weeks of enrollment.
- Failed Allen's test in both arms - unable to safely place an arterial line
- Glucose reading of < 50 mg/dL and/or episodes of symptomatic hypoglycemia requiring the assistance of another person for recovery in the 2 years prior to enrollment.
- History of hypoglycemic convulsions
- Current fluoxetine therapy (known to interfere with neuroendocrine response to hypoglycemia)
- Glycosylated hemoglobin over 8.5%
- On aldosterone antagonist therapy at the time of enrollment
- On insulin therapy at the time of screening.
- History of allergy to local anesthetic injection like lidocaine.
- Age below 21.
Exclusion Criteria for Healthy Subjects:
- Meet any of the exclusion criteria for diabetic or metabolic syndrome group Meet criteria for type 2 diabetes or metabolic syndrome
- On medication for cholesterol or blood pressure.
- History of allergy to local anesthetic injection like lidocaine.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Hypoglycemia First
Individuals will undergo a hyperinsulinemic hypoglycemic clamp in their 1st study visit after passing screening, and a euglycemic clamp in their second visit.
|
During hypoglycemic clamping, individuals will have a blood glucose level of 50-60 mg/dL for approximately 1 hour prior to outcome measurements.
During euglycemic clamping, individuals will have a blood glucose level of 85-99 mg/dL for approximately 1 hour prior to outcome measurements.
|
Eksperimentel: Euglycemia First
Individuals will undergo a hyperinsulinemic euglycemic clamp in their 1st study visit after passing screening, and a euglycemic clamp in their second visit.
|
During hypoglycemic clamping, individuals will have a blood glucose level of 50-60 mg/dL for approximately 1 hour prior to outcome measurements.
During euglycemic clamping, individuals will have a blood glucose level of 85-99 mg/dL for approximately 1 hour prior to outcome measurements.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Flow induced Dilation of the Brachial Artery (FMD%)
Tidsramme: 1 hour
|
1 hour
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Measurement of total and phosphorylated endothelium-derived NO synthase expression in radial artery endothelial cells.
Tidsramme: 1 hour
|
1 hour
|
|
Measurement of mitochondrial membrane potential
Tidsramme: 1 hour
|
Performed on captured radial artery endothelial cells.
|
1 hour
|
Mitochondrial superoxide production
Tidsramme: 1 hour
|
From capture radial artery endothelial cells.
|
1 hour
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Michael E Widlansky, MD, MPH, Medical College of Wisconsin
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
1. juni 2012
Primær færdiggørelse (Faktiske)
1. juni 2017
Studieafslutning (Faktiske)
1. juni 2017
Datoer for studieregistrering
Først indsendt
6. august 2012
Først indsendt, der opfyldte QC-kriterier
6. august 2012
Først opslået (Skøn)
8. august 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. august 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. august 2017
Sidst verificeret
1. april 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MCW-MEW3
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 .
Kliniske forsøg med Type 2 diabetes
-
Jin-Hee AhnAsan Medical CenterUkendtHER-2-genamplifikation | HER-2 Protein Overekspression
-
The University of Tennessee, KnoxvilleAfsluttetMatematiklærere (2-8 klassetrin) | Matematikstuderende (2-8 klassetrin)Forenede Stater
-
Tianjin Medical University Second HospitalJiangsu HengRui Medicine Co., Ltd.UkendtSolid tumor | HER-2-genamplifikation | HER2 genmutation | HER-2 Protein OverekspressionKina
-
PowderMedAfsluttet
-
AIM Vaccine Co., Ltd.Ningbo Rongan Biological Pharmaceutical Co. Ltd.; LiveRNA Therapeutics...Rekruttering
-
AIM Vaccine Co., Ltd.Ningbo Rongan Biological Pharmaceutical Co. Ltd.; LiveRNA Therapeutics...Ikke rekrutterer endnu
-
AIM Vaccine Co., Ltd.Ikke rekrutterer endnu
-
Sunshine Guojian Pharmaceutical (Shanghai) Co.,...Ikke rekrutterer endnu
-
University of PennsylvaniaInovio PharmaceuticalsRekruttering
-
Ridgeback Biotherapeutics, LPMerck Sharp & Dohme LLCAfsluttetSARS-CoV-2Forenede Stater
Kliniske forsøg med Glycemic clamping
-
Queen Fabiola Children's University HospitalThe Belgian Kids Fund; Fonds IRIS-Recherche; Ars StatisticaRekrutteringSepsis | For tidlig fødsel | Gulsot | Respiratory Distress Syndrome hos for tidligt fødte spædbørn | Intraventrikulær blødning af præmaturitet | BronchodysplasiBelgien
-
Marwa Mohamed FaragAfsluttet
-
Centre d'Etudes et de Recherche pour l'Intensification...AfsluttetDiabetes mellitus, type I | Justering af basal insulinflowhastighed under fysisk aktivitet | Justering af prandial insulin i tilfælde af fysisk aktivitetFrankrig