Proteinuria in Normotensive Diabetic Patients: ARBs Alone or in Combination of SGLT2i
Comparative Analysis of ARBs Alone or in Combination of SGLT2i in Management of Proteinuria in Normotensive Diabetic Patients
調査の概要
詳細な説明
Diabetes mellitus is a kind of chronic and progressive disease with high prevalence. There will be 629 million diabetic patients by 2045. About 87% to 91% diabetic patients are probably T2DM in high income countries. Diabetic kidney disease (DKD) is the leading cause of end stage renal disease (ESRD) worldwide and continues to be the major contributor to kidney replacement therapy (KRT).
Diabetic nephropathy (DN) refers to kidney damage caused by diabetes, which is one of the most common complications of diabetes. The main manifestations of DN are proteinuria, hypertension, and kidney function damage, which seriously affect the quality of life and long-term survival rate of patients. Currently, common treatments for DN in clinical practice include blood glucose control, blood pressure control and kidney protection therapy. Currently, agents such as ARBs are promising and have good availability to be used in advanced stages of CKD and4. However, the effects of ARBs on kidney outcomes, such as proteinuria unclear.
SGLT2i have become the new standard of care for slowing CKD progression in patients with T2DM due to their specific renal and cardiovascular protective effects that are independent of the main metabolic and glucose-lowering effects. Although SGLT2 inhibitors or ARBs have effects on albuminuria- and BP-lowering in patients with DKD, the effects of monotherapy are always unsatisfactory. Considering their complementary mechanisms on the kidneys, theoretically, SGLT2 inhibitors and ARBs should have synergistic action. Recently several studies indicated that the combination of SGLT2 inhibitors with ARBs satisfactorily afforded greater renoprotection than administration of either drug alone. These results demonstrated a long-term control of hyperglycemia and BP, reduction of hyperfiltration and proteinuria.
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
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-
Punjab Province
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Faisalābad、Punjab Province、パキスタン
- Faisalabad Medical University
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Both genders
- Age 30-60 years
- Diagnosed with diabetes
- Having microalbuminuria
Exclusion Criteria:
- Hypertension,
- Ischemic heart disease (IHD)
- Chromic kidney disease CKD (GFR < 60 ml/min),
- Nephrotic syndrome,
- Glomerulonephritis,
- Liver disease,
- Malignancy,
- hyperkalemia (potassium > 4.6 mmol/l)
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 |
|---|---|
|
プラセボコンパレーター:ARBs alone
Group A patients will be prescribed ARBs (losartan 50 mg/day)
|
Group A patients will be prescribed ARBs (losartan 50 mg/day)
|
|
実験的:ARBs in combination of SGLT2i
group-2 will receive SGLT2i (empagliflozin 10 mg once a day) and ARBs (losartan 50 mg/day)
|
group-2 will receive SGLT2i (empagliflozin 10 mg once a day) and ARBs (losartan 50 mg/day)
|
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 |
|---|---|---|
|
Percentage of efficacy
時間枠:one month
|
will be labeled defined as reduction of 30% or more from baseline albuminuria
|
one month
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Allied Hospital Faisalabad
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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