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Clinical Trial Details

Trial ID: L2607
Source ID: NCT01974544
Associated Drug: Best Medical Treatment
Title: Prevention and Treatment Of Diabetes Complications With Gastric Surgery or Intensive Medicines
Acronym: PRODIGIES
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Best medical treatment|PROCEDURE: gastric bypass|PROCEDURE: sleeve gastrectomy|DRUG: General interventions for all groups: blood presure|DRUG: General interventions for all groups: dysilipidemia|BEHAVIORAL: General interventions for all groups: lifestyle
Outcome Measures: Primary: Change in the microvascular complications of type 2 diabetes, specifically diabetic kidney disease, These outcome will be measured through the glomerular filtration rate (GFR), (MDRD-1 equation: GFR (expressed in ml/min/1.73 m2), and Albuminuria (ACR (mg/g)., baseline at 1 month before the intervention and 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 month after intervention|Change in the microvascular complications of type 2 diabetes, specifically Retinopathy., This will be measured through assessment by ophthalmologist., baseline at 1 month before the intervention, 12 y 24 month after intervention|Change in the microvascular complications of type 2 diabetes, specifically peripheral and sympathic neuropathy., This will be measured through assessment nerve conduction, sensory nerve conduction, motor nerve conduction, sympathic skin response., baseline at 1 month before the intervention, 12, 24 y 36 month | Secondary: Assessment of the optimization of the metabolic control, defined by the International Diabetes Federation, This will be measured through haemoglobin A1c (HbA1c) (%), continuous glucose monitoring, blood pressure (mmhg), total cholesterol (mg/dL), HDL (mg/dL), LDL (mg/dL), triglycerides (mg/dL)., baseline at 1 month before the intervention and 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 month after the intervention|Assessment of treatment complications, This will be measured through the record of all treatment complications like: Infection or surgical bleeding, inflammation of the veins for drug administration, temporary digestive disorders, gastroesophageal reflux disease, or acute retention of urine infection, prolonged pain in the area of operation. Specifically for the Gastric Bypass, intestinal fistulas poor healing of sutures, nutritional deficiencies, excessive weight loss. Less often marginal ulcerative lesions and intestinal obstruction. In the other side, the sleeve gastrectomy: dehiscence of the suture line and nutritional complications., 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 month after intervention|Assessment of the quality of life., This will be measured through the Diabetes Quality of Life Questionnaire., baseline at 1 month before the intervention and 3, 6, 12, and 24 month after the intervention|Assessment of macrovascular events, This will be measured through the record of all macrovascular events, like cardiovascular deaths, nonfatal myocardial infarction, cardiovascular interventions, nonfatal stroke, amputation or surgery for peripheral atherosclerotic artery disease., baseline at 1 month before the intervention and 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 month after the intervention|How many patients not requiring antidiabetic agents, This will be measured through the record of number of patient who requiring oral antidiabetic agent, number of patient who requiring insulin, and both., baseline 1 month after intervention, and at 6, 12, 18, 24, 30, and 36 month after intervention
Sponsor/Collaborators: Sponsor: Pontificia Universidad Catolica de Chile
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 150
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-05
Completion Date: 2016-12
Results First Posted:
Last Update Posted: 2013-11-01
Locations: Pontificia Universidad Católica de Chile, Santiago, Región Metropolitana, 8330033, Chile
URL: https://clinicaltrials.gov/show/NCT01974544