Use of Sitagliptin to Decrease Microalbuminuria
Clinical Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibitors in Urinary Albumin to Creatinine Ratio in Patients With Overt Kidney Disease
The people being asked to participate in this study have type 2 diabetes and abnormal levels of protein in their urine. This indicates that they are starting to develop diabetic kidney disease. The standard treatment for this is the use of one of two blood pressure medicines, either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). However, these medicines are not always completely effective in stopping/reversing the kidney disease. Some studies have previously suggested that another type of medicine, called sitagliptin, normal used to treat diabetes may also help prevent diabetic kidney disease from getting worse.
This study is being performed to test the effectiveness of sitagliptin as compared to a placebo, along with a stable dose of an ACE inhibitor or ARB, to determine whether or not it will reduce protein levels in their urine. Protein levels in the urine are a marker of the severity of kidney disease.
調査の概要
詳細な説明
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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Missouri
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Columbia、Missouri、アメリカ、65212
- University of Missouri-Columbia: Diabetes Center
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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:
- Albumin/creatinine ratio between 30-299 mg/dl.
- type 2 diabetes mellitus (T2DM) with hemoglobin A1c between 7 and 9%.
- Stable BP control of less than 145/90 on treatment with ACE or ARB for more than three months prior and during the trial.
- Glomerular filtration rate (GFR) of 60 mL/min/1.73m2 or more.
- Age between 18-75 years old.
- For women: at least two years postmenopausal, surgically sterile, or using an acceptable contraceptive regiment to include oral contraceptive pill (OCP), intrauterine device (IUD), double barrier, depo-provera, or subcutaneous progestin implant and negative urine pregnancy test at trial start.
Exclusion Criteria:
- Pregnancy.
- GFR less than 60 mL/min/73m2.
- Have a history of malignancy other than basal cell or squamous cell skin cancer and have not yet been treated, are currently being treated, or were diagnosed less than 5 years prior to Visit 1.
- Advanced liver disease.
- Subjects cannot be on DPP-4 inhibitor or glycolipoprotein (GLP-1) agonist for at least 4 months before the study start.
- Psychiatric condition that would prevent subject from following directions. Per PI discretion.
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
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：Sitagliptin
100 mg/day for 3 months
|
Sitagliptin 100 mg/day for 3 months
他の名前：
|
|
プラセボコンパレーター：Placebo
1 pill/day for 3 months
|
Placebo 1 pill/day for 3 months
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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 |
|---|---|---|
|
Change in Microalbuminuria Level
時間枠：Six months
|
Decrease in microalbuminuria level
|
Six months
|
協力者と研究者
捜査官
- 主任研究者：Guido Lastra Gonzalez, MD、University of Missouri-Columbia
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
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。