New Frontiers on Bariatric Surgical Procedures: Classical Bypass for Type-2 Diabetic Patients With Obesity Grade I
New Frontiers on Bariatric Surgical Procedures. Classical Bypass for Type 2 Diabetic Patients With BMI Between 30 and 34.9 kg/m2
Bariatric surgery leads to remission of type 2 diabetes in morbid obese patients in 80% (Roux-en-Y gastric bypass)to 90% (biliopancreatic diversion and duodenal switch) of cases. The current consensus supports bariatric surgical treatment for diabetic patients with BMI as low as 35kg/m2 but it has questioned that lower body mass patients might benefit of the surgery as well.
This study is proposed to describe the effects of Roux-en-Y gastric bypass in mild obese (BMI 30-35) human volunteers on incretins, insulin production and sensitivity and its clinical (diabetic chronic complications) and metabolic impact.
調査の概要
詳細な説明
Bariatric surgery leads to remission of type 2 diabetes in morbid obese patients in 80% (Roux-en-Y gastric bypass)to 90% (biliopancreatic diversion and duodenal switch) of cases; most of the remainder achieve better glycemic control, even if they regain weight. The current consensus supports bariatric surgical treatment for diabetic patients with BMI as low as 35kg/m2 but it has questioned that lower body mass patients might benefit of the surgery as well.
Actually, many clinical researchers worldwide would consider a lower limit BMI of 30kg/m2, i.e., any grade of obesity.
This study is proposed to describe the effects of Roux-en-Y gastric bypass (Fobi-Capella technique, adapted to create a larger gastric pouch, about 80ml)in mild obese (BMI 30-35) human volunteers on incretins, insulin production and sensitivity and its clinical (diabetic chronic complications) and metabolic impact.
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
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SP
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Campinas、SP、ブラジル
- LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)
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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:
- Obesity grade I (BMI 30-34,9)
- Weight variance less than 5% in the last 3 months.
- Previous diagnosis of diabetes type 2.
- Insulin requirement, alone or along with oral agents
- Capacity to understand the procedures of the study.
- To agree voluntarily to participate of the study, signing an informed consent.
Exclusion Criteria:
- Positive Anti-GAD antibodies
- Laboratorial signal of probable failure of insulin production, i. e., seric peptide C lesser than 1 ng/mL.
- History of hepatic disease like cirrhosis or chronic active hepatitis.
- Kidney dysfunction (creatinine > 1,4 mg/dl in women and > 1,5 mg/dl in men).
- Hepatic dysfunction: aspartate aminotransferase or alanine aminotransferase 3x above upper normal limit.
- Recent history of neoplasia (< 5 years).
- Use of oral or injectable corticosteroids for more than consecutive 14 days in the last three months.
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：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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実験的：1
Roux-en-Y bypass gastroplasty
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Under open laparotomy, a stomach section separates a 80-ml proximal gastric pouch.
A jejunum section below Treitz's Angle creates an excluded gastrobiliopancreatic limb of 150cm.
A Roux-in-Y retrocolic anastomosis of the alimentary limb promotes the continuity between the gastric pouch and the jejunum and a silastic ring reduces the pouch outlet.The anastomosis of the excluded limb is done 100cm below the silastic ring.
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 |
時間枠 |
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2型糖尿病の改善または逆転
時間枠：7 日、14 日、21 日、1 か月、2 か月、3 か月、6 か月、1 年。
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7 日、14 日、21 日、1 か月、2 か月、3 か月、6 か月、1 年。
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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介入後の体重と脂肪分布の変化
時間枠：1ヶ月、2ヶ月、3ヶ月、6ヶ月、1年
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1ヶ月、2ヶ月、3ヶ月、6ヶ月、1年
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頸動脈内膜 - 中膜の厚さの回帰
時間枠：1ヶ月、3ヶ月、6ヶ月、1年
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1ヶ月、3ヶ月、6ヶ月、1年
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Changes in the secretion pattern of incretins, insulin and glucagon after intervention, as measured by standardized mixed meal tolerance test
時間枠：6 months and 1 year
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6 months and 1 year
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Improvement of insulin sensitivity as measured by insulin tolerance test
時間枠：1 month, 3 months, 6 months and 1 year
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1 month, 3 months, 6 months and 1 year
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Changes in seric free fatty acids, lipoproteins, adiponectin and other adipokines
時間枠：one month, 2 months, 3 months, 6 months and 1 year
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one month, 2 months, 3 months, 6 months and 1 year
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Retardation of progression of disturbances of peripheral nerves as detected by electroneuromyography
時間枠：1 year and 2 years
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1 year and 2 years
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Retardation of progression of diabetic retinal complications as detected by fundoscopy and retinography
時間枠：1 year and 2 years
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1 year and 2 years
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Retardation of progression or regression of albuminuria as detected by microalbuminuria assay in 24-h urine collection
時間枠：6 months, 1 year and 2 years
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6 months, 1 year and 2 years
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協力者と研究者
捜査官
- 主任研究者：José Carlos Pareja, MD, PhD、University of Campinas (UNICAMP)
- 主任研究者：Bruno Geloneze, MD, PhD、University of Campinas (UNICAMP)
出版物と役立つリンク
一般刊行物
- Pories WJ, Swanson MS, MacDonald KG, Long SB, Morris PG, Brown BM, Barakat HA, deRamon RA, Israel G, Dolezal JM, et al. Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg. 1995 Sep;222(3):339-50; discussion 350-2. doi: 10.1097/00000658-199509000-00011.
- Pories WJ, MacDonald KG Jr, Flickinger EG, Dohm GL, Sinha MK, Barakat HA, May HJ, Khazanie P, Swanson MS, Morgan E, et al. Is type II diabetes mellitus (NIDDM) a surgical disease? Ann Surg. 1992 Jun;215(6):633-42; discussion 643. doi: 10.1097/00000658-199206000-00010.
- Geloneze B, Tambascia MA, Pilla VF, Geloneze SR, Repetto EM, Pareja JC. Ghrelin: a gut-brain hormone: effect of gastric bypass surgery. Obes Surg. 2003 Feb;13(1):17-22. doi: 10.1381/096089203321136539.
- Geloneze B, Tambascia MA, Pareja JC, Repetto EM, Magna LA. The insulin tolerance test in morbidly obese patients undergoing bariatric surgery. Obes Res. 2001 Dec;9(12):763-9. doi: 10.1038/oby.2001.105.
- Pories WJ. Diabetes: the evolution of a new paradigm. Ann Surg. 2004 Jan;239(1):12-3. doi: 10.1097/01.sla.0000102990.47956.98.
- Fellici AC, Lambert G, Lima MM, Pareja JC, Rodovalho S, Chaim EA, Geloneze B. Surgical treatment of type 2 diabetes in subjects with mild obesity: mechanisms underlying metabolic improvements. Obes Surg. 2015 Jan;25(1):36-44. doi: 10.1007/s11695-014-1377-9.
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
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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