The Effect of Gastric Bypass Surgery on Diabetes
Laihdutusleikkauksen Vaikutus Diabetekseen
This study will investigate the effects of gastric bypass surgery on type II diabetes. The study will recruit patients with type II diabetes having Roux-en-Y gastric bypass, patients without type II diabetes having Roux-en-Y gastric bypass, and control subjects (patients having gastroscopy, but no surgery). Targeted enrollment is 30 patients per group. Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy. Meal test with incretin measurements, and feces and blood samplings are performed before and after surgery
Hypotheses are:
- The pathogenesis of type II diabetes is linked to changes in the expression of intestinal endocrine cells
- The changes in the incretine excretion after the gastric bypass surgery partly explain the amelioration of type II diabetes
- The oxidation of lipoprotein is diminished after the gastric bypass surgery slowing the development of atherosclerosis
- The immunologic functions of the intestine are changed by the gastric bypass surgery attenuating systemic inflammation
- The gastric bypass surgery changes cholesterol and bile acid metabolism
- The gastric bypass surgery changes the fecal microbiota
Primary end points are:
- Changes in the amounts of endocrine cells in ventricle, duodenum and jejunum
- Changes in the incretine secretion studied with liquid meal test
- Changes in the oxidation of lipoproteins
- Changes in the immunologic markers in ventricle, duodenum and jejunum
- Changes in the amounts of phytosterols, cholesterol metabolites and bile acids
- Changes in fecal microbiota
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Oulu、フィンランド、90220
- Oulu University Hospital
-
-
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria (patients with surgery):
- Patients having Roux-en-Y gastric bypass (according to clinical guidelines)
- Age: 18-65 years
Inclusion Criteria (control patients without surgery):
- Patients having gastroscopy (for various clinical reasons)
Exclusion Criteria:
- Diabetes (applies for control patients)
- BMI over 30 (applies for control patients)
- Insulin treatment
- Oral corticosteroid treatment
- Chronic inflammatory disease
- Coeliac disease
- Malignant disease
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
コホートと介入
グループ/コホート |
---|
Patients with diabetes having Roux-en-Y gastric bypass
|
Patients without diabetes having Roux-en-Y gastric bypass
|
Control subjects (patients having gastroscopy, no surgery)
|
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 |
---|---|---|
Changes in the amounts of endocrine cells in ventricle, duodenum and jejunum
時間枠:baseline to 6 months
|
Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
|
baseline to 6 months
|
Changes in the incretine secretion studied with liquid meal test
時間枠:baseline to 6 months
|
Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
|
baseline to 6 months
|
Changes in the oxidation of lipoproteins
時間枠:baseline to 6 months
|
Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
|
baseline to 6 months
|
Changes in the immunologic markers in ventricle, duodenum and jejunum
時間枠:baseline to 6 months
|
Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
|
baseline to 6 months
|
Changes in the amounts of phytosterols, cholesterol metabolites and bile acids
時間枠:baseline to 6 months
|
Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
|
baseline to 6 months
|
Changes in fecal microbiota
時間枠:baseline to 6 months
|
Samples of intestine are taken prior to surgery in gastroscopy, during surgery, and 6 months after surgery during gastroscopy
|
baseline to 6 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Vesa Koivukangas, MD, PhD、Oulu University Hospital
出版物と役立つリンク
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。
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