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The Effects of Hypoglycaemia in People With Type 2 Diabetes

2014年7月31日 更新者：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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

18

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

  • イギリス
      • Hull、イギリス、HU3 2RW
        • Hull Royal Infirmary

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

40年～60年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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

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：診断
  • 割り当て：非ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：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.
薬：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.
他の名前：
  • Glucose (20% Dextrose).
デバイス：Euglycaemic Hypoglycaemic Insulin clamp
アクティブコンパレータ：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.
薬：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.
他の名前：
  • Glucose (20% Dextrose).
デバイス：Euglycaemic Hypoglycaemic Insulin clamp

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
To examine the effect of hypoglycaemia on platelet surface expression of platelet activation markers P-selectin and fibrinogen binding.
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
To measure changes in markers of inflammation (high sensitivity C-reactive protein) and endothelial function using EndoPat 2000
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
To assess the effects of hypoglycaemia on participants scores on cognitive function tests
時間枠：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

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。

スポンサー

University of Hull

協力者

Hull University Teaching Hospitals NHS Trust

捜査官

  • 主任研究者：Stephen L Atkin, PhD、Hull York Medical School

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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

2011年11月1日

一次修了 (実際)

2013年5月1日

研究の完了 (実際)

2013年5月1日

試験登録日

最初に提出

2014年7月28日

QC基準を満たした最初の提出物

2014年7月31日

最初の投稿 (見積もり)

2014年8月1日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年8月1日

QC基準を満たした最後の更新が送信されました

2014年7月31日

最終確認日

2014年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 11/YH/0161

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