- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01974544
Prevention and Treatment Of Diabetes Complications With Gastric Surgery or Intensive Medicines (PRODIGIES)
Study Overview
Status
Conditions
Detailed Description
Currently 205 million patients in the world suffer with Type 2 diabetes and severe and complex obesity. The obesity is defined as a body mass index above 30 kg/m2 with life or limb threatening co-morbidities.
The bariatric surgery increase in worldwide, but their effects on the microvascular complications of T2DM have never been the focus of a randomised controlled clinical trial.
To address this research question a three arms on randomised controlled clinical trial comparing gastric bypass surgery, sleeve gastrectomy and modern best medical care is required to investigate differences in long term glycaemia and microvascular complications of T2DM.
This is a prospective intervention study on patients with T2DM and obesity undergoing gastric bypass surgery, sleeve gastrectomy or non surgical best medical care. Patients will have T2DM for more than 2 years and have or be at high risk of developing kidney damage. Patients will be recruited from specialist medical and surgical clinics.
We expect to screen approximately 300 patients to allow 75 to be randomized. Twenty five subjects with kidney damage or high risk of kidney damage secondary to T2DM will undergo gastric bypass surgery. Another 25 sleeve gastrectomy and the final 25 will be treated using the American Diabetes Association protocol. Patients with HbA1c ≥9.0% will undergo individualised optimisation of glycaemia as this should improve surgical outcomes. Particular attention will be given to the avoidance of hypoglycaemia. Patients' other risk factors (including hypertension and dyslipidaemia) will be optimised based on the International Diabetes Federation guidelines.
The clinical endpoints that will be assessed are: renal function, peripheral and autonomic nervous system function, the retina, of direct healthcare cost, glycaemic control, blood pressure, lipids, quality of life, postprandial responses, treatment complications.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Castillo Alejandra
- Phone Number: 56223543257
- Email: macastia@uc.cl
Study Contact Backup
- Name: Vega Andrea
- Phone Number: 56223543879
- Email: abvega@uc.cl
Study Locations
-
-
Región Metropolitana
-
Santiago, Región Metropolitana, Chile, 8330033
- Recruiting
- Pontificia Universidad Catolica de Chile
-
Contact:
- Castillo Alejandra, Nurse
- Phone Number: 56223543527
- Email: macastia@uc.cl
-
Contact:
- Vega Andrea, Nurse
- Phone Number: 56223543879
- Email: abvega@uc.cl
-
Principal Investigator:
- Boza Camilo, MD surgeon
-
Sub-Investigator:
- Valderas Juan Patricio, MD
-
Sub-Investigator:
- Arrese Marco, MD Internist
-
Sub-Investigator:
- Muñoz Rodrigo, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Type 2 diabetes with HbA1c > 7%
- Duration of diabetes of more than 2 years
- The glomerular filtration rate (GFR) > 30 ml/min per 1.73 m2
- BMI < 35 kg/m2
- Age 18-65
- Established microalbuminuria or at high risk of microalbuminuria
Exclusion Criteria:
- Type 1 diabetes or positive Glutamic acid decarboxylase antibodies (Anti-GAD)
- BMI >35 kg/m2
- End stage retinopathy, nephropathy or neuropathy (defined as high risk/advanced proliferative retinopathy on the Early Treatment Diabetic Retinopathy Study Severity Scale or blindness, Stage 5 chronic kidney disease, patients requiring dialysis or transplantation, Stage 3 peripheral neuropathy)
- Unacceptably high risk for general anaesthesia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Best medical treatment
Fifty obese patients with kidney damage or high risk of kidney damage secondary to T2DM will will be treated using the American Diabetes Association protocol.
Also this arm will be treated like: General interventions for all groups: blood presure, General interventions for all groups: dysilipidemia and General interventions for all groups: lifestyle establishes.
|
If patients are unable to maintain their haemoglobin A1c (HbA1c) values below 6.5% on diet alone, treatment with metformin 1g twice daily will be started.
If HbA1c remains above 7.0% then liraglutide 0.6 mg once daily (with a subsequent increases to 1.2 mg and 1.8 mg once daily).
If liraglutide is not tolerated then a Dipeptidyl peptidase IV inhibitor (sitagliptin, saxagliptin, linagliptin) or pioglitazone will be considered.
If HbA1c remains above 7.5% long acting insulin analogues such as detemir o glargine will be added.
If insulin is started liraglutide can be stopped.
The insulin dose will be adjusted according to the morning fasting blood glucose concentration.
Finally, Fast-acting meal time insulin (lispro, aspart or glulisine) will be added if glycemic goal is not achieved.
Repaglinide can be considered in patients with significant renal impairment and in patients who refused insulin treatment.
Other Names:
Patients will receive an angiotensin-converting-enzyme (ACE) inhibitor or angiotensin II receptor antagonists (ARA II) to meet strict blood pressure targets of the ADA / European Association for Study of Diabetes (EASD) or in the presence of micro or macroalbuminuria.
In addition to ACE inhibitors (or if there were side-effects, an angiotensin-II receptor antagonist), calcium antagonist, diuretics or Beta blockers can be added as needed.
Aspirin 100 mg daily will be used for secondary prevention in patients with a history of ischaemic cardiovascular disease.
Other Names:
Raised fasting serum cholesterol concentrations (greater than 4.5 mmol/L) or combined dyslipidaemias will be treated with atorvastatin 10-80mg once daily.
Gemfibrozilo or fenofibrate once daily can be used for isolated hypertriglyceridaemia (fasting serum triglyceride concentration >4.0 mmol/L), or fenofibrate can be added to statin treatment if the fasting serum triglyceride concentration was also raised (>4.0 mmol/L).
Other Names:
Exercise is an important part of the diabetes management plan.
The ADA recommendations for the adults with diabetes is at least 150 min/week of moderate-intensity aerobic physical activity (50-70% of maximum heart rate), with no more than two consecutive days without exercise.
A kinesiologist will design an individual plan of physical training for each patient.
Also, a nutritionist will be design an individual dietitian plan, this plan should be formulated as a collaborative therapeutic alliance among the patient and family, physician, and other members of the health care team.
Other Names:
|
EXPERIMENTAL: gastric bypass surgery
Fifty obese patients with kidney damage or high risk of kidney damage secondary to T2DM will undergo gastric bypass surgery, in the conventional procedure.
Also this arm will be treated like: General interventions for all groups: blood presure, General interventions for all groups: dysilipidemia and General interventions for all groups: lifestyle establishes.
|
Patients will receive an angiotensin-converting-enzyme (ACE) inhibitor or angiotensin II receptor antagonists (ARA II) to meet strict blood pressure targets of the ADA / European Association for Study of Diabetes (EASD) or in the presence of micro or macroalbuminuria.
In addition to ACE inhibitors (or if there were side-effects, an angiotensin-II receptor antagonist), calcium antagonist, diuretics or Beta blockers can be added as needed.
Aspirin 100 mg daily will be used for secondary prevention in patients with a history of ischaemic cardiovascular disease.
Other Names:
Raised fasting serum cholesterol concentrations (greater than 4.5 mmol/L) or combined dyslipidaemias will be treated with atorvastatin 10-80mg once daily.
Gemfibrozilo or fenofibrate once daily can be used for isolated hypertriglyceridaemia (fasting serum triglyceride concentration >4.0 mmol/L), or fenofibrate can be added to statin treatment if the fasting serum triglyceride concentration was also raised (>4.0 mmol/L).
Other Names:
Exercise is an important part of the diabetes management plan.
The ADA recommendations for the adults with diabetes is at least 150 min/week of moderate-intensity aerobic physical activity (50-70% of maximum heart rate), with no more than two consecutive days without exercise.
A kinesiologist will design an individual plan of physical training for each patient.
Also, a nutritionist will be design an individual dietitian plan, this plan should be formulated as a collaborative therapeutic alliance among the patient and family, physician, and other members of the health care team.
Other Names:
For the gastric bypass, the gastric pouch will be adjusted to a volume of 15-20 ml.
The alimentary limb will be a standard 150 cm and the biliopancreatic limb 50 cm.
A hand-sewn gastro-jejunal anastomosis will be performed over a 34 French bougie
|
EXPERIMENTAL: sleeve gastrectomy
Fifty obese patients with kidney damage or high risk of kidney damage secondary to T2DM will undergo sleeve gastrectomy surgery, in the conventional procedure.
Also this arm will be treated like: General interventions for all groups: blood presure, General interventions for all groups: dysilipidemia and General interventions for all groups: lifestyle establishes.
|
Patients will receive an angiotensin-converting-enzyme (ACE) inhibitor or angiotensin II receptor antagonists (ARA II) to meet strict blood pressure targets of the ADA / European Association for Study of Diabetes (EASD) or in the presence of micro or macroalbuminuria.
In addition to ACE inhibitors (or if there were side-effects, an angiotensin-II receptor antagonist), calcium antagonist, diuretics or Beta blockers can be added as needed.
Aspirin 100 mg daily will be used for secondary prevention in patients with a history of ischaemic cardiovascular disease.
Other Names:
Raised fasting serum cholesterol concentrations (greater than 4.5 mmol/L) or combined dyslipidaemias will be treated with atorvastatin 10-80mg once daily.
Gemfibrozilo or fenofibrate once daily can be used for isolated hypertriglyceridaemia (fasting serum triglyceride concentration >4.0 mmol/L), or fenofibrate can be added to statin treatment if the fasting serum triglyceride concentration was also raised (>4.0 mmol/L).
Other Names:
Exercise is an important part of the diabetes management plan.
The ADA recommendations for the adults with diabetes is at least 150 min/week of moderate-intensity aerobic physical activity (50-70% of maximum heart rate), with no more than two consecutive days without exercise.
A kinesiologist will design an individual plan of physical training for each patient.
Also, a nutritionist will be design an individual dietitian plan, this plan should be formulated as a collaborative therapeutic alliance among the patient and family, physician, and other members of the health care team.
Other Names:
The sleeve gastrectomy will be done using laparoscopic staplers over a 34 French bougie.The greater curvature will be dissected 4 cm proximal to the pylorus leaving the antrum.
Short gastric vessels will be dissected using the harmonic scalpel up to the gastro-esophageal junction.
The stapler will be reinforced.
The resected stomach will be removed in a plastic bag through the left flank trocar
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the microvascular complications of type 2 diabetes, specifically diabetic kidney disease
Time Frame: baseline at 1 month before the intervention and 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 month after intervention
|
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
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Change in the microvascular complications of type 2 diabetes, specifically Retinopathy.
Time Frame: baseline at 1 month before the intervention, 12 y 24 month after intervention
|
This will be measured through assessment by ophthalmologist.
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baseline at 1 month before the intervention, 12 y 24 month after intervention
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Change in the microvascular complications of type 2 diabetes, specifically peripheral and sympathic neuropathy.
Time Frame: baseline at 1 month before the intervention, 12, 24 y 36 month
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This will be measured through assessment nerve conduction, sensory nerve conduction, motor nerve conduction, sympathic skin response.
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baseline at 1 month before the intervention, 12, 24 y 36 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of the optimization of the metabolic control, defined by the International Diabetes Federation
Time Frame: baseline at 1 month before the intervention and 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 month after the intervention
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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).
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baseline at 1 month before the intervention and 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 month after the intervention
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Assessment of treatment complications
Time Frame: 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 month after intervention
|
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
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Assessment of the quality of life.
Time Frame: baseline at 1 month before the intervention and 3, 6, 12, and 24 month after the intervention
|
This will be measured through the Diabetes Quality of Life Questionnaire.
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baseline at 1 month before the intervention and 3, 6, 12, and 24 month after the intervention
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Assessment of macrovascular events
Time Frame: 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
|
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.
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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
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How many patients not requiring antidiabetic agents
Time Frame: baseline 1 month after intervention, and at 6, 12, 18, 24, 30, and 36 month after intervention
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This will be measured through the record of number of patient who requiring oral antidiabetic agent, number of patient who requiring insulin, and both.
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baseline 1 month after intervention, and at 6, 12, 18, 24, 30, and 36 month after intervention
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Collaborators and Investigators
Investigators
- Principal Investigator: Boza Camilo, MD surgeon, Pontificia Universidad Catolica de Chile
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-141
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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