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The Effects of Hypoglycaemia in People With Type 2 Diabetes

31. Juli 2014 aktualisiert von: Thozhukat Sathyapalan, University of Hull

The Effects of Hypoglycaemia on Platelets Function and Inflammatory Markers in People With Type 2 Diabetes and Normal Controls.

Strict glycaemic control has been associated with increased hypoglycaemia and mortality rate, the cause of which was unclear, in subjects with type 2 diabetes. In this study, we hypothesised that acute hypoglycaemia will result in platelet activation in people with type 2 diabetes to a higher degree than controls.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Type 2 diabetes is associated with increased risk of cardiovascular disease. Although the United Kingdom Prospective Diabetes Study (UKPDS) follow-up data suggested reduced macrovascular complications with tight glycaemic control, recent studies in people with type 2 diabetes failed to replicate these findings. Furthermore, all-cause mortality was found to be increased with strict glycaemic control in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study. The cause of the increased deaths remains unclear.

Strict glycaemic control is associated with increased risk of hypoglycaemia. Although, hypoglycaemia has traditionally been considered a complication of the treatment for type 1 diabetes, it has recently been recognised as a problem in people with type 2 diabetes particularly those on insulin therapy. In the ACCORD study, the risk of death was significantly increased in those with one or more episode of severe hypoglycaemia in both the strict and standard study treatment arms. As plasma glucose falls to below 4.0 mmol/L, a series of defence mechanisms occur, at an individualised glycaemic thresholds, to reverse hypoglycaemia including a rise in catecholamine levels. This may lead to hypokalaemia, prolonged QT interval, and cardiac arrhythmias. It may also lead to impaired cardiovascular autonomic function for up to 16 hours afterwards; increased inflammatory markers; platelet activation and promote vascular damage. As the majority of studies assessing the effects of hypoglycaemia on cardiovascular risk markers are conducted in people with type 1 diabetes and healthy controls, their findings may not necessarily be applicable to people with type 2 diabetes. In particular, the effects of hypoglycaemia on platelet function and thrombotic risk in people with type 2 diabetes require further clarification. In this study, we hypothesised that acute hypoglycaemia will result in platelet activation in people with type 2 diabetes to a higher degree than controls.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

18

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

40 Jahre bis 60 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  1. Healthy volunteers:

    • Males or females
    • On no medications except for the contraceptive pill and without medical illnesses in the last three months.
    • Non-smokers
    • 40 - 60 years of age.

  2. T2DM subjects:

    • Males or females
    • Diagnosis of T2DM
    • 40 - 60 years of age
    • HbA1C: 6.5 - 9.5%
    • Duration of diabetes 1 - 10 years
    • Diabetes treated with diet, or tablets only.

Exclusion Criteria:

  1. Healthy volunteers:

    • Pregnancy
    • Lack of contraception in women of child bearing age
    • Chronic medical conditions
    • Current smokers
    • Evidence of ischaemia on ECG
    • Drop attacks
    • Alcohol or drug abuse
    • Psychiatric illness
    • Previous history of seizure
    • Alcohol or drug abuse

  2. Type 2 diabetes subjects:

    • Pregnancy
    • Current smokers
    • Recurrent episodes of hypoglycaemia
    • Treatment with anti-platelet or anti-coagulation therapy
    • History of ischaemic heart disease, stroke or peripheral vascular disease
    • Epilepsy
    • Drop attacks
    • Evidence of ischaemia on ECG
    • Insulin treated T2DM
    • History of microvascular disease (retinopathy, nephropathy or neuropathy).
    • Alcohol or drug abuse
    • Psychiatric illness

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Controls
Weight-matched healthy controls. Euglycaemic Hypoglycaemic insulin clamp. Using hyperinsulinaemic clamps, blood glucose levels were stabilised over 1 hour to reach 5 mmol/L and maintained at that level for 1 hour, then gradually reduced over 1 hour to 2.8 mmol/L and maintained at that level for 1 hour. Blood samples were collected at times 0 (baseline), 2 hours (euglycaemia), 4 hours (hypoglycaemia) and at 24 hours after the clamp studies.
Arzneimittel: Insulin (Humulin S)
Using insulin and glucose infusions (hyperinsulinaemic clamps), blood glucose levels were stabilised over 1 hour to reach 5 mmol/L and maintained at that level for 1 hour, then gradually reduced over 1 hour to 2.8 mmol/L and maintained at that level for 1 hour. Blood samples were collected at times 0 (baseline), 2 hours (euglycaemia), 4 hours (hypoglycaemia) and at 24 hours after the clamp studies.
Andere Namen:
  • Glucose (20% Dextrose).
Gerät: Euglycaemic Hypoglycaemic Insulin clamp
Aktiver Komparator: Type 2 diabetes
People with a known diagnosis of type 2 diabetes. Euglycaemic Hypoglycaemic Insulin clamp. Using hyperinsulinaemic clamps, blood glucose levels were stabilised over 1 hour to reach 5 mmol/L and maintained at that level for 1 hour, then gradually reduced over 1 hour to 2.8 mmol/L and maintained at that level for 1 hour. Blood samples were collected at times 0 (baseline), 2 hours (euglycaemia), 4 hours (hypoglycaemia) and at 24 hours after the clamp studies.
Arzneimittel: Insulin (Humulin S)
Using insulin and glucose infusions (hyperinsulinaemic clamps), blood glucose levels were stabilised over 1 hour to reach 5 mmol/L and maintained at that level for 1 hour, then gradually reduced over 1 hour to 2.8 mmol/L and maintained at that level for 1 hour. Blood samples were collected at times 0 (baseline), 2 hours (euglycaemia), 4 hours (hypoglycaemia) and at 24 hours after the clamp studies.
Andere Namen:
  • Glucose (20% Dextrose).
Gerät: Euglycaemic Hypoglycaemic Insulin clamp

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
To examine the effect of hypoglycaemia on platelet surface expression of platelet activation markers P-selectin and fibrinogen binding.
Zeitfenster: Up to 24 hours after euglycaemic hypoglycaemic clamp

Platelet surface expression of activation markers, P-selectin and fibrinogen binding, were measured in the resting state (unstimulated samples) and in response to stimulation with platelet agonist adenosine diphosphate, and platelet inhibitor prostacyclin.

A change in platelet function from times 0 (baseline), to 2 hours (euglycaemia), 4 hours (hypoglycaemia) and 24 hours after the clamp studies was measured and compared between the two groups.
Up to 24 hours after euglycaemic hypoglycaemic clamp

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
To measure changes in markers of inflammation (high sensitivity C-reactive protein) and endothelial function using EndoPat 2000
Zeitfenster: Up to 24h after euglycaemic hypoglycaemic clamp

High sensitivity C-reactive protein was measured at baseline (time 0), 2 hours (euglycaemia), 4 hours (hypoglycaemia) and 24 hours after clamp studies. Changes from baseline were compared between the groups.

EndoPat was measured before the insulin clamp and 24 hours afterwards and changes were compared between the two groups.
Up to 24h after euglycaemic hypoglycaemic clamp

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
To assess the effects of hypoglycaemia on participants scores on cognitive function tests
Zeitfenster: Up to 24h after euglycaemic hypoglycaemic clamp
Three cognitive function tests (Tower of Hanoi; Dual Task test and The Digit symbol-coding) were measured at baseline (time 0), 2 hours (euglycaemia), 4 hours (hypoglycaemia) and 24 hours after insulin clamp studies. Changes from baseline in each of these tests in response to the insulin clamp were compared between the two groups.
Up to 24h after euglycaemic hypoglycaemic clamp

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Hull

Mitarbeiter

Hull University Teaching Hospitals NHS Trust

Ermittler

  • Hauptermittler: Stephen L Atkin, PhD, Hull York Medical School

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. November 2011

Primärer Abschluss (Tatsächlich)

1. Mai 2013

Studienabschluss (Tatsächlich)

1. Mai 2013

Studienanmeldedaten

Zuerst eingereicht

28. Juli 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

31. Juli 2014

Zuerst gepostet (Schätzen)

1. August 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

1. August 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

31. Juli 2014

Zuletzt verifiziert

1. Juli 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 11/YH/0161

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