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Beta-cell Response to Incretin Hormones in Cystic Fibrosis 45

募集中
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT01851694 は 介入研究 臨床試験 で、嚢胞性線維症、膵機能不全 に関するものです。現在は 募集中 で、2013年5月1日 から開始しています。45 名の参加者 の募集が計画されています。この試験は ペンシルベニア大学 によって主導され、2026年12月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年1月14日 です。
概要
In recent years, diabetes has emerged as one of the most significant co-diseases that many Cystic Fibrosis (CF) patients develop. Type 1 (T1D) and Type 2 (T2D) diabetes results when either the body does not make enough insulin or the body does not respond correctly to this insulin, respectively. Insulin is a hormone which is made by cells in the pancreas and helps carry glucose (sugar) from the food we eat to the cel...もっと見る
詳細説明
Previously, cystic fibrosis related diabetes (CFRD) was considered to be a consequence of damage to the pancreas therefore the cells contained in the pancreas--i.e.--islets that house beta cells, which make and release insulin (similar to T1D). Recent evidence suggests that other factors may also be associated that are similar to those with T2D. For example, patients with T2D, have decreased secretion of incretins, h...もっと見る
公式タイトル

Determination of Beta-cell Responsiveness to the Incretin Hormones GLP-1 and GIP in Cystic Fibrosis

疾患名
嚢胞性線維症膵機能不全
刊行物
この臨床試験について発表された科学記事と研究論文：
その他の研究識別子
  • 817585
NCT番号
NCT01851694
開始日
2013-05
最終更新日
2026-01-14
終了予定日
2026-12
目標参加者数
45
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
Cystic Fibrosis
Diabetes
Pancreatic insufficiency
Cystic Fibrosis with Normal Glucose Tolerance
Non-Cystic Fibrosis control group
主目的
その他
割付方法
無作為化
介入モデル
並行割当
盲検化
四重盲検
群（アーム）／介入
参加グループ/群介入/治療法
実験的GLP-1 Incretin Hormone
The incretin, Glucagon-Like-peptide-1 (GLP-1) will be infused into the veins starting 30 minutes prior to initiating the GPA test. This infusion will continue for a total of 90 mins. (during the GPA for 230 mg/dL glucose levels) and then this will be stopped. The GPA test will be performed for the 340 mg/dL glucose levels but no incretin will be infused during this part of the test. These data will be compared when t...もっと見る
GLP-1
Each subject in this arm will receive GLP-1 infusion and a placebo infusion during a GPA test.
実験的GIP Incretin Hormone
The incretin, Glucose-dependent Insulinotropic Polypeptide (GIP) will be infused into the veins starting 30 minutes prior to initiating the GPA test. This infusion will continue for a total of 90 mins (during the GPA for 230 mg/dL glucose levels) and then this will be stopped. The GPA test will be performed for the 340 mg/dL glucose levels but no incretin will be infused during this part of the test. These data will ...もっと見る
GIP
Each subject in this arm will receive GIP infusion and placebo during a GPA test.
主要評価項目
評価指標指標の説明時間枠
Second-phase insulin response during GPA test
The key endpoint of interest will be the change in second phase insulin response derived from the Glucose-Potentiated Arginine (GPA) test. The GPA test will measure insulin (and other glucose controlling hormones) which will be a measure of pancreatic endocrine function in response to injection of arginine. Arginine is a naturally occurring amino acid (substance) in the body. It will be given in the veins to make the pancreas secrete insulin. After the first injection of arginine, a glucose infusion will be started in order to raise the level of sugar in the blood to 230 mg/dl. Once the level is achieved, arginine will be injected again and blood samples are measured. After a 2 hour break, the glucose infusion will be started to achieve a blood sugar of 340mg/dl and arginine injection will be repeated. Comparison of responses with incretin vs. placebo will be performed using statistical methods, specifically, paired t-test or Wilcoxon matched pair test.
5 hours
副次評価項目
評価指標指標の説明時間枠
Change in insulin secretion among CF groups
The change in second phase insulin secretion induced by incretins will be compared among the different subgroups of patients with CF (Ind-GT, IGT, and early CFRD) groups using nonparametric comparison of changes in slope, estimated using Mann-Whitney methods.
5 hours
参加アシスタント
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
健康なボランティアを受け入れる
はい
  1. Confirmed diagnosis of cystic fibrosis, defined by positive sweat test or CFTR mutation analysis according to CFF diagnostic criteria,
  2. Age greater than or equal to 18y on date of consent
  3. Pancreatic insufficiency
  4. Recent OGTT consistent with Indeterminate-GT, IGT, CFRD w/o fasting hyperglycemia, or an established diagnosis of CFRD without fasting hyperglycemia
  5. For female subjects, negative urine pregnancy test at enrollment.

Control Subjects:

  1. No history of cystic fibrosis.
  2. Age ≥ 18y on date of consent.
  3. Recent OGTT consistent with NGT.
  4. For female subjects, negative urine pregnancy test at enrollment.

  1. Established diagnosis of non-CF diabetes (i.e. T1D) or CFRD with fasting hyperglycemia (fasting glucose greater than126 mg/dL)
  2. History of clinically symptomatic pancreatitis within last year
  3. Prior lung or liver transplant
  4. Severe CF liver disease, as defined by portal hypertension
  5. Fundoplication-related dumping syndrome
  6. Medical co-morbidities that are not CF-related or are unstable per investigator opinion (i.e. history of bleeding disorders, immunodeficiency)
  7. Acute illness or changes in therapy (including antibiotics) within 6 weeks prior to study procedures
  8. Treatment with oral or intravenous corticosteroids within 6 weeks of study
  9. Hemoglobin less than10g/dL, within 90 days of Visit 1 or at Screening
  10. Abnormal renal function, within 90 days of Visit 1 or at Screening; defined as Creatinine greater than 2x upper limit of normal (ULN) or potassium greater than 5.5mEq/L on non-hemolyzed specimen
  11. Inability to perform study specific procedures (MMTT, GPA)
  12. Subjects, who in study team opinion, may be non-compliant with study procedures.

Control Subjects who will be exposed to GIP only:

  1. History of clinically symptomatic pancreatitis.
  2. History of liver disease.
  3. History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk to the subject.
  4. Hemoglobin <10g/dL, within 90 days of GPA test or at Screening.
  5. Abnormal renal function, within 90 days of GPA test or at Screening; defined as creatinine > 2x upper limit of normal (ULN) or potassium > 5.5mEq/L on non-hemolyzed specimen.
  6. Inability to perform study specific procedures (MMTT, GPA).
  7. subjects, who in study team opinion, may be non-compliant with study procedures.
  8. elevation of serum amylase or lipase > 1.5x ULN within 90 days of GPA test.
University of Pennsylvania logoペンシルベニア大学503 件のアクティブな治験を探索
Children's Hospital of Philadelphia logoChildren's Hospital of Philadelphia
責任者
Michael R. Rickels, MD, MS, 主任研究者, Professor of Medicine, University of Pennsylvania
試験中央連絡先
連絡先: Paola Alvarado, 215-746-2081, [email protected]
1 1カ国の場所

Pennsylvania

Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, Pennsylvania, 19060, United States
Paola Alvarado, 連絡先, 215-746-2081, [email protected]
Michael Rickels, M.D., M.S, 主任研究者
Andrea Kelly, M.D, M.S., 主任研究者
募集中