Intestinal Remodeling And Reprogramming of Glucose Metabolism Following Laparoscopic Roux-en-Y Gastric Bypass
The purpose of this study is to investigate small intestinal remodeling and reprogramming of glucose metabolism in patients with Type 2 Diabetes Mellitus (T2DM) who undergo laparoscopic Roux-en-Y Gastric Bypass (RYGB). Our specific goal is to determine if the gene and protein expression levels of GLUT-1 are up regulated in the Roux limb and whether this is a major mechanism for the remission of T2DM following RYGB.
The two aims of the study are: 1) to demonstrate that the basement membrane glucose transporter 1 (GLUT-1) is upregulated in the Roux limb following RYGB, and 2) to demonstrate that the upregulation of GLUT-1 is a major mechanism for the improvement in glycemic control observed in T2DM patients undergoing RYGB.
調査の概要
状態
研究の種類
段階
- 適用できない
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:
- Diagnosis of Type 2 Diabetes Mellitus
- Age between 18 and 65 years of age
- BMI > 35kg/m²
- Diagnosis of gastritis, esophagitis, ulcer, or other mucosal abnormality discovered at routine preoperative upper endoscopy, requiring follow-up endoscopy in the post-operative period.
Exclusion Criteria:
- Patients undergoing revision from another bariatric procedure to RYGB
- Presence of a seizure disorder (GLUT-1 deficiency syndrome)
- Use of Tricyclic antidepressants
- Use of tobacco products
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:基礎科学
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- 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 |
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他の:RYGB with mucosal abnormality on EGD
Subjects with Type 2 Diabetes undergoing a Roux-en-Y Gastric Bypass with a diagnosis of gastritis, esophagitis, ulcer, or other mucosal abnormality discovered at routine preoperative upper endoscopy, requiring follow-up endoscopy in the post-operative period.
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Before Surgery: Subjects will have a visit where they will have a mixed nutrient stimulation test.
They will be asked to fast for 12 hours prior to this visit (except water).
During the visit they will drink an 8 ounce mixed nutrient liquid meal in 5 minute intervals over 20 minutes.
During this visit a catheter will be placed in a vein in their arm for blood sample collections.
A total of 50 ml of blood will be collected, (10 ml before drinking the mixed nutrient drink, at 30 minutes, at 60 minutes, at 90 minutes and 120 minutes after the mixed nutrient drink).
Fasting Plasma Glucose (FPG) and insulin will be added to the standard pre-operative labs.
Intra-operatively: Subjects will undergo a standard laparoscopic Roux-en-Y Gastric Bypass (RYGB).
During the surgery a 2cm tissue sample of the Roux limb will be taken by the doctor and frozen.
2 months post-operatively a second mixed nutrient stimulation test will be performed following the same process used pre-operatively.
. Patients will also be scheduled to undergo a second upper endoscopy and a 2cm biopsy of the Roux limb will be taken by the doctor and frozen in liquid nitrogen.
Lastly, subjects will have a positron emission tomography/computed tomography (PET/CT) scan with Fluorodeoxyglucose (FDG) to evaluate the glucose in the Roux limb after surgery.
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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 |
---|---|---|
Elevated Glut-1 gene and protein expression levels
時間枠:2 months
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Gene and protein expression levels of GLUT-1 will be analyzed from the specimens obtained intra-operatively (baseline) and at 2 months post-operatively to determine if levels are significantly elevated above baseline.
Quantitative real-time PCR and Western blot techniques will be utilized as described in C below.
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2 months
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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 |
---|---|---|
Glut-1 level change in fasting glucose
時間枠:2 months
|
Change in GLUT-1 levels will be correlated with changes in fasting glucose, mixed meal stimulation test, and homeostasis model assessment (HOMA).
Secondly, at 2 months post-operatively, whole-body positron emission tomography/computed tomography (PET/CT) scanning with Fluorodeoxyglucose (FDG) will be performed to evaluate glucose uptake and utilization in the Roux limb.
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2 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Philip Omotosho, MD、Duke University
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 (見積もり)
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
キーワード
その他の研究ID番号
- Pro00054934
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。
Mix Nutrient Mealの臨床試験
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Wageningen UniversityUniversity of Nairobi; Nestlé Foundation; Nevin Scrimshaw International Nutrition Foundation完了