The Benefits of Intensive Glycemic Control in Elderly Patients With Type 2 Diabetes
Aims/hypothesis:
Populations worldwide are aging and type 2 diabetes is common in individuals aged >80 years. The important issue that needs to be considered is whether tight glycemic control is benefits for elderly patients with type 2 diabetes. The benefits of intensive glucose control remain uncertain for the heterogeneous population of older diabetic patients due to a lack of clinical trial data evaluating the benefits of long-term intensive glucose control in older patients. This study is designed to provide reliable evidence on the balance of benefits and risks conferred by intensive glucose control in elderly patients with type 2 diabetes Methods: This is a prospective, randomized, open-labeled, controlled design to assess the benefits of treating elderly patients with type 2 diabetes. The study will include 208 elderly patients with type 2 diabetes and follow-up for 5 years. Eligible patients are randomized to receive intensive (A1C <7.0%) or conservative (A1C around 8.0%) glycemic control. The primary study outcomes are a composite of macrovascular events and a composite of microvascular events, considered both jointly and separately. The secondary outcomes are death from any cause, death from cardiovascular causes, total coronary events, total cerebrovascular events, heart failure, peripheral vascular events, all cardiovascular events, and hospitalization for 24 hours or more.
Expected results: This study is designed to provide reliable evidence on the balance of benefits and risks conferred by intensive and conservative glucose control in elderly patients with type 2 diabetes. Once completed, this trial will clearly influence the management of elderly patients with type 2 diabetes, regardless of the results.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Taipei、台湾、11217
- 募集
- Chen-Hsen Lee
-
コンタクト:
- Harn-Shen Chen, MD, PhD
-
-
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:
- Men or women aged ≥80 years at time of randomization.There is no upper age limit.
- Be able to walk by themselves
- They had their first diagnosis of type 2 diabetes mellitus at age 30 years or older.
Exclusion Criteria:
- Known advanced diabetic complications (such as proliferative retinopathy, chronic kidney disease stage IV or above).
- Overt clinical congestive heart failure (CHF) requiring treatment with a diuretic or ACE inhibitor.
- Previous documented cerebral or subarachnoid haemorrhage in the last 6 months
- Condition expected to severely limit survival
- Clinical diagnosis of dementia
- Resident in a nursing home
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: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 |
---|---|
実験的:1
Fasting plasma glucose (mg/dL) 90 to 130 Glycated hemoglobin (%) 6.0 to 7.0
|
Intensive glycemic control
|
アクティブコンパレータ:2
Fasting plasma glucose (mg/dL) 90 to 180 Glycated hemoglobin (%) 7.0 to 9.0
|
OADs and insulin
|
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 |
時間枠 |
---|---|
The primary study outcomes are a composite of macrovascular events and a composite of microvascular events, considered both jointly and separately.
時間枠:Every 6 months and up to 5 years
|
Every 6 months and up to 5 years
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
The secondary outcomes are death from any cause, disability from any cause, total coronary events, total cerebrovascular events, heart failure, peripheral vascular events, all cardiovascular events, and hospitalization for 24 hours or more.
時間枠:Every 6 months and upto 5 years
|
Every 6 months and upto 5 years
|
協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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
本研究に関する用語
キーワード
その他の研究ID番号
- VGHIRB 97-12-04
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。
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