Surgical Techniques in Diabetes Mellitus-II and Obesity. Metabolic Surgery Study (MSS) (MSS)
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|ClinicalTrials.gov Identifier: NCT02310555|
Recruitment Status : Unknown
Verified December 2014 by Juan Lujan, Hospital Universitario Virgen de la Arrixaca.
Recruitment status was: Recruiting
First Posted : December 8, 2014
Last Update Posted : December 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Obesity||Procedure: Gastric bypass Procedure: Modified gastric bypass. Procedure: Slevee Gastrectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prospective Randomised Study Comparing Surgical Techniques in Patients With Diabetes Mellitus-II And Obesity|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||May 2015|
|Estimated Study Completion Date :||May 2016|
Active Comparator: Gastric bypass
classic Gastric bypass
Procedure: Gastric bypass
Active Comparator: Modified gastric bypass.
Modified gastric bypass. Resection body and fundus gastric
Procedure: Modified gastric bypass.
Active Comparator: Slevee Gastrectomy
Procedure: Slevee Gastrectomy
- Remission diabetes mellitus type II [ Time Frame: Durign two years ]
- Partial remission: Not diagnostic of DM HbA1c (<6.5%); Basal glucose 100-125 mg / dl (5.6-6.9 mmol / l); Absence of drug treatment; At least one year.
- Complete remission: Normal HbA1c (<6%); basal glucose <100 mg / dl (<5.6 mmol / l); Absence of drug treatment; At least one year.
- Prolonged remission: At least 5 years of remission.
- Improvement: HbA1c <7% with pharmacological treatment.
- Weight loss [ Time Frame: During two years ]
- Adverse effects in the short term [ Time Frame: During three months since surgery ]We'll measure the number of patients with postoperative complications and the the degree of severity of Clavien- Dindo Classification
- Adverse effects in the long term [ Time Frame: Since third month after surgery untiil two years ]We'll measure the number of patients with postoperative complications and the the degree of severity of Clavien- Dindo Classification
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310555
|Contact: Juan A. Luján Mompean, Ph D; Section chief||968369677|
|Contact: Pascual Parrilla Paricio, Ph D; Department head|
|Hospital Clínico Universitario Virgen de la Arrixaca||Recruiting|
|El Palmar., Murcia, Spain, 30120|
|Contact: Juan A. Luján, Ph D 968369677|
|Principal Investigator: Juan A. Luján, Ph D|
|Principal Investigator:||Juan A. Luján Mompean, Ph D; Section chief||Hospital Clínico Universitario Virgen Arrixaca|