Genetic Variants Replication Study Associated With Dependence on Sulfonylurea in Participants With Type 2 Diabetes
調査の概要
詳細な説明
Sulfonylurea, one of the oral hypoglycemic agents, is the oldest and most widely used drug. The use of sulfonylurea was overwhelming compared to metformin especially in East Asia, where insulin secretion was notable during the pathophysiology of type 2 diabetes. However, sulfonylurea causes hypoglycemia and weight gain, increases cardiovascular disease and mortality compared to other oral preparations. With the recent development of other oral hypoglycemic agents for lowering blood glucose without the risk of hypoglycemia and with cardiovascular protection, sulfonylurea is in a decreasing state of use worldwide.
But some patients tend to be highly dependent on sulfonylurea for blood glucose control. It suggests that there will be a group of patients whose the action of sulfonylurea is strongly influenced by genetic factor, since insulin secretion of pancreatic beta cells is very hereditary, genetic variations that increase the risk of type 2 diabetes are found mainly in genes related to beta cell dysfunction rather than insulin resistance, and the more risk variants of type 2 diabetes, the less likely the effect of sulfonylurea is.
The investigators had performed whole exome sequencing in patients showing dependence on sulfonylurea and identified tens of candidate variants.
In this study, the investigators will select patients with dependence on sulfonylurea by prospective intervention (by discontinuing and resuming sulfonylurea) and perform genetic tests.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Seoul、大韓民国、110-144
- Seoul National University Hospital
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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:
Among patients with type 2 diabetes who visited Seoul National University Hospital endocrinology outpatient clinic, all of criteria (1)-(4) are satisfied
- Adults over 19 years
- More than 10 years of diabetes
- Low dose sulfonylurea use: Equivalent capacity 2 mg or less of glimepiride
- Less than 7.5% of glycated hemoglobin for more than 6 months
- estimated glomerular filtration rate > 50 mL/min/1.73㎡
Exclusion Criteria:
- Type 1 diabetics
- Insulin user
- Patients diagnosed with cardiovascular disease, cancer, and other critical illness within 6 months before the study
- Patients with severe hypertension
- Patients with treatment or diseases that may have a significant effect on blood glucose levels, such as glucocorticoids and thyrotoxicosis
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：なし
- 介入モデル：単一グループの割り当て
- 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 |
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実験的：Sulfonylurea-dependent
Sulfonylurea is replaced by alternative oral hypoglycemic agent.
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他の名前：
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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 |
|---|---|---|
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the list of previously found candidate variants which are observed in the slufonylurea-dependent patients but not in the non-dependent patients
時間枠：20 weeks
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Dependency on sulfonylurea-dependency is determined according to changes in HbA1c by use of sulfonylurea.
The 'previously found candidate variants' are the results from whole exome sequencing in patients showing dependence on sulfonylurea as a screening before.
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20 weeks
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協力者と研究者
捜査官
- 主任研究者：Hye Seung Jung, MD、Seoul National University Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
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