Type 2 DiabetesPRODIGIESNCT01974544
Prevention and Treatment Of Diabetes Complications With Gastric Surgery or Intensive Medicines
A study testing Best medical treatment, gastric bypass and sleeve gastrectomy in people with Type 2 Diabetes, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
The obesity and type 2 diabetes mellitus (T2DM) are among the most threatening health crisis for the 21st century. Currently, it is estimated that there are 205 million people with T2DM worldwide. Chile has a similar magnitude of problem with the prevalence of diabetes increasing from 6.3% in 2003 to 9.4% in 2010. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Best medical treatment, gastric bypass and sleeve gastrectomy
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChile
- Study dates
- May 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Pontificia Universidad Católica de Chile
Santiago, Santiago Metropolitan, 8330033
Castillo Alejandra, Nurse, 56223543527, macastia@uc.cl
Vega Andrea, Nurse, 56223543879, abvega@uc.cl
About this study
The obesity and type 2 diabetes mellitus (T2DM) are among the most threatening health crisis for the 21st century. Currently, it is estimated that there are 205 million people with T2DM worldwide. Chile has a similar magnitude of problem with the prevalence of diabetes increasing from 6.3% in 2003 to 9.4% in 2010. T2DM is a complex disease characterized by hyperglycemia, insulin resistance and a relative β-cell failure. Well-known studies for the treatment of T2DM (ADVANCE trial) showed that intensive medical treatment significantly reduces the complication of diabetes. On the other hand, less than 40% of patients with T2DM achieve a metabolic control of diabetes, despite medical treatment. Recently, bariatric surgery has emerged as an effective treatment for T2DM. Data from different sources has shown that Roux-en-Y Gastric Bypass (RYGB) can place T2DM into remission. More recently, Sleeve Gastrectomy (SG) has been shown to also impact metabolically and hence also emerged as an attractive T2DM-controlling bariatric procedure with fewer complications than RYGB. Recently, the International Federation for Diabetes has supported the use gastrointestinal surgery initially developed for morbid obesity as an option to treat patients with diabetes. In the current proposal the investigators aim to address several issues concerning metabolic surgery and the ability of the most common bariatric procedures performed to control diabetes. The investigators are proposing a prospective randomized trial comparing RYGB, SG and the best medical treatment availed for the T2DM in poorly control patients with the primary endpoint being 36 month glycemic control (patients achieving HbA1C < 6.5%, normal glucose levels not requiring medication). The main working hypothesis is that RYGB and SG achieves better glycemic control than the best treatment availed for the T2DM based on more effective mechanisms to enhance insulin secretion, insulin sensitivity, lipid metabolism and blood pressure control. The goals are, 1) Is gastric bypass surgery and sleeve gastrectomy safe for the microvascular complications of T2DM?; 2) Can gastric bypass, sleeve gastrectomy surgery and intensive non surgical treatment reverse or reduce the progression of microvascular complications of T2DM?; and 3) Can gastric bypass and sleeve gastrectomy realize a return on investment within 2 years in patients with type 2 diabetes who are at risk of developing or deteriorating microvascular complications?
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Best medical treatment, gastric bypass, sleeve gastrectomy, General interventions for all groups: blood presure, General interventions for all groups: dysilipidemia
- Keywords
- diabetes complications, metabolic surgery, Intensive medicines
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best medical treatmentDrug
Also called Non surgical interventions, Glycemic control drugs
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.
gastric bypassProcedure or surgery
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
sleeve gastrectomyProcedure or surgery
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
General interventions for all groups: blood presureDrug
Also called Management elevated blood pressure in patients with T2DM
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.
General interventions for all groups: dysilipidemiaDrug
Also called Management of dyslipidemia
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).
General interventions for all groups: lifestyleBehavioural
Also called Therapeutic lifestyle modification
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.
| Study group | Role | What they receive |
|---|---|---|
| Best medical treatment | Experimental | 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. Receives: Drug: Best medical treatment; Drug: General interventions for all groups: blood presure; Drug: General interventions for all groups: dysilipidemia; Behavioral: General interventions for all groups: lifestyle |
| gastric bypass surgery | Experimental | 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. Receives: Procedure: gastric bypass; Drug: General interventions for all groups: blood presure; Drug: General interventions for all groups: dysilipidemia; Behavioral: General interventions for all groups: lifestyle |
| sleeve gastrectomy | Experimental | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: baseline at 1 month before the intervention, 12, 24 y 36 month
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline 1 month after intervention, and at 6, 12, 18, 24, 30, and 36 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boza Camilo, MD surgeon, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974544
- Sponsor's protocol ID
- 11-141
- Acronym
- PRODIGIES
- Status last verified
- Oct 2013
- First submitted
- 25 May 2013
- Last updated
- 1 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Treatment Of Diabetes Complications With Gastric Surgery or Intensive Medicines
- ClinicalTrials.gov ID
- NCT01974544
- Acronym / sponsor ID
- PRODIGIES / 11-141
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes complications, metabolic surgery, Intensive medicines
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The obesity and type 2 diabetes mellitus (T2DM) are among the most threatening health crisis for the 21st century. Currently, it is estimated that there are 205 million people with T2DM worldwide. Chile has a similar magnitude of problem with the prevalence of diabetes increasing from 6.3% in 2003 to 9.4% in 2010. T2DM is a complex disease characterized by hyperglycemia, insulin resistance and a relative β-cell failure. Well-known studies for the treatment of T2DM (ADVANCE trial) showed that intensive medical treatment significantly reduces the complication of diabetes. On the other hand, less than 40% of patients with T2DM achieve a metabolic control of diabetes, despite medical treatment. Recently, bariatric surgery has emerged as an effective treatment for T2DM. Data from different sources has shown that Roux-en-Y Gastric Bypass (RYGB) can place T2DM into remission. More recently, Sleeve Gastrectomy (SG) has been shown to also impact metabolically and hence also emerged as an attractive T2DM-controlling bariatric procedure with fewer complications than RYGB. Recently, the International Federation for Diabetes has supported the use gastrointestinal surgery initially developed for morbid obesity as an option to treat patients with diabetes. In the current proposal the investigators aim to address several issues concerning metabolic surgery and the ability of the most common bariatric procedures performed to control diabetes. The investigators are proposing a prospective randomized trial comparing RYGB, SG and the best medical treatment availed for the T2DM in poorly control patients with the primary endpoint being 36 month glycemic control (patients achieving HbA1C < 6.5%, normal glucose levels not requiring medication). The main working hypothesis is that RYGB and SG achieves better glycemic control than the best treatment availed for the T2DM based on more effective mechanisms to enhance insulin secretion, insulin sensitivity, lipid metabolism and blood pressure control. The goals are, 1) Is gastric bypass surgery and sleeve gastrectomy safe for the microvascular complications of T2DM?; 2) Can gastric bypass, sleeve gastrectomy surgery and intensive non surgical treatment reverse or reduce the progression of microvascular complications of T2DM?; and 3) Can gastric bypass and sleeve gastrectomy realize a return on investment within 2 years in patients with type 2 diabetes who are at risk of developing or deteriorating microvascular complications?
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Best medical treatment | Experimental | Drug: Best medical treatment, Drug: General interventions for all groups: blood presure, Drug: General interventions for all groups: dysilipidemia, Behavioral: General interventions for all groups: lifestyleFifty 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. |
| gastric bypass surgery | Experimental | Procedure: gastric bypass, Drug: General interventions for all groups: blood presure, Drug: General interventions for all groups: dysilipidemia, Behavioral: General interventions for all groups: lifestyleFifty 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. |
| sleeve gastrectomy | Experimental | Procedure: sleeve gastrectomy, Drug: General interventions for all groups: blood presure, Drug: General interventions for all groups: dysilipidemia, Behavioral: General interventions for all groups: lifestyleFifty 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best medical treatmentAlso: Non surgical interventions, Glycemic control drugsIf 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. | Drug | Best medical treatment |
| gastric bypassFor 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 | Procedure or surgery | gastric bypass surgery |
| sleeve gastrectomyThe 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 | Procedure or surgery | sleeve gastrectomy |
| General interventions for all groups: blood presureAlso: Management elevated blood pressure in patients with T2DMPatients 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. | Drug | Best medical treatment, gastric bypass surgery, sleeve gastrectomy |
| General interventions for all groups: dysilipidemiaAlso: Management of dyslipidemiaRaised 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). | Drug | Best medical treatment, gastric bypass surgery, sleeve gastrectomy |
| General interventions for all groups: lifestyleAlso: Therapeutic lifestyle modificationExercise 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. | Behavioural | Best medical treatment, gastric bypass surgery, sleeve gastrectomy |
Primary outcome
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).
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.
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
This will be measured through assessment nerve conduction, sensory nerve conduction, motor nerve conduction, sympathic skin response.
5 secondary outcomes
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
Assessment of treatment complications
Time frame: 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 month after intervention
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boza Camilo, MD surgeon principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best medical treatment, gastric bypass and sleeve gastrectomy in people with Type 2 Diabetes, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Castillo Alejandra (56223543257, macastia@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2013.