Inpatient Diabetes on Corticosteroids
2019年9月9日 更新者：Hennepin Healthcare Research Institute
Despite a significant problem with out-of-control glucose levels in patients with diabetes receiving corticosteroids for a variety of illnesses, there are no published protocols addressing how to adequately treat corticosteroid-induced hyperglycemia.
Investigators propose to test a protocol using scheduled dosing of NPH (Neutral protamine Hagedorn) insulin for inpatients with diabetes receiving corticosteroids.
NPH insulin action is ideally timed to counteract corticosteroid-induced hyperglycemia, and the dose is added to the patient's usual insulin regimen and timed to correspond to the corticosteroid dosing regimen.
Investigators will prospectively enroll eligible consented patients with diabetes who are receiving corticosteroids as part of their treatment in a large county hospital, will randomize them to intervention or control groups, and will monitor their glucose levels during their inpatient stay.
The protocol will demonstrate improved control of glucose levels with minimal risk of hypoglycemia, and will provide a practical and readily implementable protocol using NPH insulin as therapy for corticosteroid-induced diabetes.
調査の概要
詳細な説明
As above.
研究の種類
介入
入学 (実際)
85
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Minnesota
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Minneapolis、Minnesota、アメリカ、55415
- Hennepin County Medical Center
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～79年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Prior history of diabetes
- Able to provide informed consent
- Receiving corticosteroids while hospitalized of greater than 10 mg/d prednisone or the equivalent of dexamethasone or methylprednisolone
- Expect to be hospitalized for 48 hours
Exclusion Criteria:
- Renal failure with GFR (glomerular filtration rate) < 30 ml/min/1.73m2
- ALT (alanine aminotransferase) > 2 times upper normal for laboratory
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：NPH with steroid dose
Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg |
NPH given per study table based on steroid dose and patient weight in kg.
他の名前：
Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl.
Administered qid during study duration.
他の名前：
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アクティブコンパレータ：Control - Background and correction insulin
Receive usual care with background insulin and correction factor for duration of study (2-5 days)
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Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl.
Administered qid during study duration.
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 |
|---|---|---|
|
Mean POC Glucose Level Between Groups
時間枠：Assessed from enrollment to discharge or enrollment to day five.
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Primary outcome measure was mean blood glucose levels measured pre-meal and at bedtime in study patients and controls for the duration of the intervention.
Values shown are the overall mean point of care blood glucose.
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Assessed from enrollment to discharge or enrollment to day five.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Episodes of Hypoglycemia Between NPH and Control Groups
時間枠：Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown represent cumulative episodes of hypoglycemia per group.
|
Hypoglycemia was defined as point of care glucose less than 70 mg/dL.
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Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown represent cumulative episodes of hypoglycemia per group.
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Point of Care Glucose Measurements Between 70 - 180 mg/dL
時間枠：From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
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Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention.
Values shown are the overall percentage of glucose measurements between 70 - 180 mg/dl.
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From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
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Incidence of Hyperglycemia Defined as Point of Care Glucose 180 - 300 mg/dL
時間枠：From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
|
Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention.
Values shown are the overall percentage of glucose measurements 180 - 300 mg/dL.
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From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
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Incidence of Hyperglycemia Defined as Point of Care Glucose 300 - 400 mg/dl
時間枠：From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
|
Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention.
Values shown are the overall percentage of glucose measurements 300 - 400 mg/dl.
|
From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
|
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Incidence of Hyperglycemia Defined as Point of Care Glucose > 400 mg/dL
時間枠：From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
|
Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention.
Values shown are the overall percentage of glucose measurements > 400 mg/dL.
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From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
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Difference in Length of Stay Between NPH and Control Group
時間枠：Measured from the day of admission till the day of discharge
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Time difference of hospitalization between the NPH and control groups.
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Measured from the day of admission till the day of discharge
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Mean Point of Care (POC) Glucose Level in Both Groups.
時間枠：On day 1 of study enrollment. Point of care glucose was checked before breakfast, lunch, dinner, and bed time.
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The overall mean point of care glucose levels in the NPH group and control group on the first day of the study.
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On day 1 of study enrollment. Point of care glucose was checked before breakfast, lunch, dinner, and bed time.
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Mean Point of Care (POC) Glucose Level in Both Groups.
時間枠：On day 5 or last day of hospitalization (if less than 5 days) glucose level as measured by point of care glucose before breakfast, lunch, dinner and bed time.
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The overall mean point of care glucose levels in the NPH group and control group on the last day of the study.
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On day 5 or last day of hospitalization (if less than 5 days) glucose level as measured by point of care glucose before breakfast, lunch, dinner and bed time.
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Correlation of C-peptide With Age
時間枠：plasma C-peptide was measured once at the time of enrollment
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plasma C-peptide was measured once at the time of enrollment
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Correlation of C-peptide With BMI
時間枠：Measured once at the time of enrollment
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Measured once at the time of enrollment
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Correlation of C-peptide With eGFR
時間枠：Measured once at the time of enrollment
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Measured once at the time of enrollment
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Correlation of C-peptide With Serum Creatinine
時間枠：Measured once at the time of enrollment
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Measured once at the time of enrollment
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Correlation of C-peptide With ALT
時間枠：Measured once at the time of enrollment
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Measured once at the time of enrollment
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Correlation of C-peptide With Hemoglobin A1c
時間枠：Measured once at the time of enrollment
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Measured once at the time of enrollment
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Correlation of C-peptide With Duration of Diabetes
時間枠：Measured once at the time of enrollment
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Measured once at the time of enrollment
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Correlation of C-peptide With Plasma Glucose
時間枠：Measured the time of enrollment
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Measured the time of enrollment
|
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Correlation of C-peptide With Length of Stay
時間枠：Measured once at the time of enrollment
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Measured once at the time of enrollment
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Lisa Fish, MD、Hennepin County Medical Center, Minneapolis
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2014年7月1日
一次修了 (実際)
2016年6月1日
研究の完了 (実際)
2016年6月1日
試験登録日
最初に提出
2013年9月4日
QC基準を満たした最初の提出物
2013年10月24日
最初の投稿 (見積もり)
2013年10月28日
学習記録の更新
投稿された最後の更新 (実際)
2019年10月1日
QC基準を満たした最後の更新が送信されました
2019年9月9日
最終確認日
2019年9月1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。