Study Protocol for Rosiglitazone Versus Gliclazide in Diabetics With Angina
Effects of Rosiglitazone and Sulphonylureas on Ischaemic Burden, Blood Pressure and Novel Risk Markers Inclusive of Vascular Function in Patients With Chronic Stable Angina and Type 2 Diabetes Mellitus: A Randomised, Double-Blinded Study.
The principle objective of the trial is to compare rosiglitazone to gliclazide in patients with type 2 diabetes mellitus and chronic stable angina to see how the subjects' angina status changes.
Angina status will be measured via exercise tolerance testing, 24-hour ECG testing and angina quality of life questionnaire.
調査の概要
詳細な説明
Ischaemic heart disease is one of the main complications of type 2 diabetes mellitus, both in terms of morbidity and mortality. Reducing plasma glucose with hypoglycaemic agents has not been shown to improve cardiovascular mortality or morbidity. Chronic stable angina is a common problem in patients with type 2 diabetes mellitus.
We postulate that in subjects with uncontrolled type 2 diabetes mellitus (Hba1c >7.5%), on metformin therapy, and chronic stable angina that the addition of the insulin sensitiser, rosiglitazone to control their diabetes will improve their angina when compared to the addition of the hypoglycaemic agent gliclazide. This hypothesis is based on the fact that insulin resistance is an upstream mechanism common to both conditions.
We will randomise such patients to 3 months therapy of rosiglitazone or gliclazide for 3 months, comparing angina status before and after by way of full Bruce protocol exercise testing, 24 hour ST segment analysis and angina questionnaire.
研究の種類
入学
段階
- フェーズ 4
連絡先と場所
研究場所
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Glasgow、イギリス、G4 0SF
- Cardiology Department, Glasgow Royal Infirmary
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Chronic stable angina with ongoing symptoms. (The treatment goal being an improvement in symptoms)
- Participants will have uncontrolled diabetes (Hba1c>7.5) on metformin monotherapy (so the diabetes is not over treated)
- Participants will be diabetic for less than 8 years.
Exclusion Criteria:
- Renal impairment (creatinine >130mmol/l)
- Hepatic Impairment (ALT>70U/l, AST>80U/l)
- Any clinical signs of heart failure
- Physical disability precluding treadmill exercise tolerance testing
- Abnormal resting ECG (left or right bundle-branch block, left or right ventricular hypertrophy, ventricular preexcitation, Q-wave myocardial infarction, digitalis therapy)
- Women of childbearing potential
- Women who are breastfeeding
研究計画
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
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 |
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Angina status at 3 months
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二次結果の測定
結果測定 |
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Pulse wave velocity at 3 months
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Small vessel function at 3 months
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Haemostatic markers at 3 months
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Biochemical markers of inflammation at 3 months
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Naveed Sattar, MBChB PhD、University of Glasgow
- 主任研究者：Stuart M Cobbe, MBChB MD、University of Glasgow
研究記録日
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。