Diabetes MellitusMSO1CTNCT03891056
Metabolic Surgery; Gastric Bypass vs Sleeve Gastrectomy; Efects Over Type 2 DM With Bad Metabolic Control (MSO1CT)
A study testing metabolic surgery in people with Diabetes Mellitus and Metabolic Surgery, run by Hospital Universitario Doctor Peset at 1 site in Spain.
Trial summary
The aim of the study is to compare the efficacy of laparoscopic gastric bypass versus vertical gastrectomy for the resolution of DM in patients with BMI 30-35. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Metabolic Surgery, Sleeve Gastrectomy
- What is being tested?
- metabolic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2019to Jan 2022
- 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
- Both sex patients aged between 18 and 65 years old
- Class I obesity (BMI 30-35 kg/m2) with bad metabolic control (DM-2 with HbA1c > 7,5%) and non-insulin anti-diabetic treatment failure (it is necessary >10 years of known diabetes evolution time, C-peptide≥ 1 ng/ml, no insulin treatment, at least two oral hypoglycemic agents treatment);
- Patients who accomplish the follow-up protocol designed by both Surgery and Endocrinology departments
- Informed consent signed
Who cannot join
- Patients who do not accomplish the previosly described inclusion criteria; Patient's refusal to take part in the study; Patients with symptomatology of gastroesophageal reflux disease or with upper gastrointestinal series compatible with this desease.
- Previous bariatric surgery
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Department of General and Digestive Surgery of the Dr. Peset Hospital
Valencia, 46017
Nuria Peris Tomás, PhD, 0034 617019132, nuriapt27@gmail.com
Jose Angel Diez Ares, PhD, 0034 619702452, jose_angel_diez_ares@hotmail.com
About this study
Official title: METABOLIC SURGERY FOR PATIENTS WITH TYPE 2 DM AND GRADE I OBESITY (BMI 30-35 kg/m2) WITH BAD METABOLIC CONTROL (HbA1c > 7,5%) PROTOCOL
The aim of the study is to compare the efficacy of laparoscopic gastric bypass versus vertical gastrectomy for the resolution of DM in patients with BMI 30-35.
Read the detailed description
Hyphotesis Laparoscopic gastric bypass is the elective technique in the face of sleeve gastrectomy to improve or heal type 2 diabetes mellitus in patientes with BMI 30-35 kg/m2.
MAIN AIM:
To compare cure rate through the improvement in glycated hemoglobin and fasting glycaemia after laparoscopic gastric bypass face to sleeve gastrectomy.
SECONDARY AIMS:
To quantify both insulin and oral hypoglycemic agents dose decrease. To measure weight loss and its maintenance during the follow-up in both techniques.
To compare postoperative complications. To compare postoperative pain. To compare follow-up complications.
Matherial and methods. Type of study: Randomized clinical trial double blind with two paralel groups.
RANDOMIZATION. Randomization will be a simple one with Epidat 4.1. A number sequence will be carried out and it will be kept in opaque closed envelopes. The envelope will be opened the operation day and the surgery technique will be decided randomly, according to the randomization sequence. The study will be blinded for patients, who will not know the surgery technique they will go on. Dieticians and Endocrinologists who will follow the patients up after the surgery neither will not know it, so differences in dietary recommendations will not appear with this masking.
Subjects of study The study will rely on patients with Diabetes Mellitus type 2 and grade I obesity with HbA1c higher than 7,5 % (BMI 30-35 kg/m2 and type 2 diabetes with bad glycemic control) detected in Endocrinology and Nutrition Department of Hospital Doctor Peset. Patients will go on bariatric surgery in General and Digestive Surgery Department of the same hospital. Patients who accomplish established inclusion criteria will be recruited until sample size is completed; a minimum 40 patients size is estimated (with a type I error of 5% and a power of 80%) and the will be randomized in two 20 people branches. Investigation will follow The World Medical Association and Declaration of Helsinki guidelines.
Definition of healing and improvement. Healing will be defined when HbA1c and fasting glycaemia levels are inside normal limits without needing oral hypoglycemic agents.
Improvement will be defined when decreasing medication doses for keeping normal fasting glycaemia and level of HbA1c under 6%.
Period of study:
The required one for fulfilling the sample. An inclusion of 40 patients in two years is expected.
Variable-gathering period The patient will be call for attending the external consultation of the Endocrinology and Nutrition Department of Hospital Doctor Peset. Each subject will carry out an initial study with nutritional status assesment, cardiovascular risk factors and comorbidities (hypertension, obstructive sleep apnea, dyslipidemia), as well as discarding secondary causes of obesity. In basal state, 2 days, 3, 6 and 12 months after the surgery, a blood test consisting of biochemical analysis, specific proteins, serum hormones, inmunological markers, full blood count and hemostasis will be made. The patient will carry out dietary intervention and follow-up in each phase of the process.
- Conditions
- Diabetes Mellitus, Metabolic Surgery, Sleeve Gastrectomy, BPGY
- Being tested
- metabolic surgery
- Keywords
- Diabetes Mellitus, Metabolic Surgery, BMI 30-35, BPGY, Vertical Gastrectomy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metabolic surgeryProcedure or surgery
The study will randomize patients into two arms, one where a laparoscopic gastric bypass will be performed and another that will perform slevee gastrectomy.
| Study group | Role | What they receive |
|---|---|---|
| Gastric bypass | Active comparator | Twenty patients will be randomly assigned to perform a laparoscopic gastric bypass. Receives: Procedure: metabolic surgery |
| Slevee gastrectomy | Active comparator | Twenty patients will be randomly assigned to perform a sleeve gastrectomy Receives: Procedure: metabolic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participans with normal glycosylated hemoglobin levels
Healing will be defined when HbA1c and fasting glycaemia levels are inside normal limits (Hb1Ac < 6%, FBG<100mg/dl) without needing oral hypoglycemic agents.
Measured: 1 year after surgery
Secondary outcomes (4)
Number of participants with partial remission or improvement of diabetes
Partial remission: Subdiabetic hyperglycemia (Hb1Ac 6%-6,4%, FBG 100-125mg/dl) in the absence anti diabetic medication.
Improvement: statistically significant reduction in Hb1Ac and FBG not meeting criteria for remission or decrease in anti diabetic medication requirement (by one oral agent, or 1/2 reduction in dose)
Measured: 1 year after surgery
Comparison of weight loss between the two techniques; bypass and sleeve.
To measure weight loss and its maintenance during the follow-up in both techniques. For this, the patients will be weighed in the postoperative period at month, 3, 6 12 months and then annually.
Measured: 2 years after surgery
Evaluation of postoperative complications in patients undergoing bypass and slevee with Clavien-Dindo classification.
Grade I: any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgesics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside.
Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutritional also included.
Grade III: Requiring surgical, endoscopic or radiological intervention. Grade IV: Life-threatening complication requiring IC/ICU management. Grade V: Death of a patient.
Measured: 1 month after surgery
Comparison postoperative pain in sleeve and bypass with analogue assessment scale of postoperative pain.
The postoperative pain of the patients during the first three postoperative days will be evaluated with the visual analogue scale from 0 (no pain) to 10 (unbearable pain).
Measured: 3 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start15 Jan 2019
- Primary completionJan 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Model description
- Randomization will be a simple one with Epidat 4.1. A number sequence will be carried out and it will be kept in opaque closed envelopes. The envelope will be opened the operation day and the surgery technique will be decided randomly, according to the randomization sequence.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Doctor Peset
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuria Peris Tomás, Hospital Universitario Doctor Peset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891056
- Sponsor's protocol ID
- MSO1CT
- Acronym
- MSO1CT
- Status last verified
- Mar 2019
- First submitted
- 6 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- METABOLIC SURGERY FOR PATIENTS WITH TYPE 2 DM AND GRADE I OBESITY (BMI 30-35 kg/m2) WITH BAD METABOLIC CONTROL (HbA1c > 7,5%) PROTOCOL
- ClinicalTrials.gov ID
- NCT03891056
- Acronym / sponsor ID
- MSO1CT / MSO1CT
- Conditions
- Diabetes Mellitus, Metabolic Surgery, Sleeve Gastrectomy, BPGY
- Keywords
- Diabetes Mellitus, Metabolic Surgery, BMI 30-35, BPGY, Vertical Gastrectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Universitario Doctor PesetUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 26 Mar 2019 (actual)
- 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 aim of the study is to compare the efficacy of laparoscopic gastric bypass versus vertical gastrectomy for the resolution of DM in patients with BMI 30-35.
Detailed description
Hyphotesis Laparoscopic gastric bypass is the elective technique in the face of sleeve gastrectomy to improve or heal type 2 diabetes mellitus in patientes with BMI 30-35 kg/m2.
MAIN AIM:
To compare cure rate through the improvement in glycated hemoglobin and fasting glycaemia after laparoscopic gastric bypass face to sleeve gastrectomy.
SECONDARY AIMS:
To quantify both insulin and oral hypoglycemic agents dose decrease. To measure weight loss and its maintenance during the follow-up in both techniques.
To compare postoperative complications. To compare postoperative pain. To compare follow-up complications.
Matherial and methods. Type of study: Randomized clinical trial double blind with two paralel groups.
RANDOMIZATION. Randomization will be a simple one with Epidat 4.1. A number sequence will be carried out and it will be kept in opaque closed envelopes. The envelope will be opened the operation day and the surgery technique will be decided randomly, according to the randomization sequence. The study will be blinded for patients, who will not know the surgery technique they will go on. Dieticians and Endocrinologists who will follow the patients up after the surgery neither will not know it, so differences in dietary recommendations will not appear with this masking.
Subjects of study The study will rely on patients with Diabetes Mellitus type 2 and grade I obesity with HbA1c higher than 7,5 % (BMI 30-35 kg/m2 and type 2 diabetes with bad glycemic control) detected in Endocrinology and Nutrition Department of Hospital Doctor Peset. Patients will go on bariatric surgery in General and Digestive Surgery Department of the same hospital. Patients who accomplish established inclusion criteria will be recruited until sample size is completed; a minimum 40 patients size is estimated (with a type I error of 5% and a power of 80%) and the will be randomized in two 20 people branches. Investigation will follow The World Medical Association and Declaration of Helsinki guidelines.
Definition of healing and improvement. Healing will be defined when HbA1c and fasting glycaemia levels are inside normal limits without needing oral hypoglycemic agents.
Improvement will be defined when decreasing medication doses for keeping normal fasting glycaemia and level of HbA1c under 6%.
Period of study:
The required one for fulfilling the sample. An inclusion of 40 patients in two years is expected.
Variable-gathering period The patient will be call for attending the external consultation of the Endocrinology and Nutrition Department of Hospital Doctor Peset. Each subject will carry out an initial study with nutritional status assesment, cardiovascular risk factors and comorbidities (hypertension, obstructive sleep apnea, dyslipidemia), as well as discarding secondary causes of obesity. In basal state, 2 days, 3, 6 and 12 months after the surgery, a blood test consisting of biochemical analysis, specific proteins, serum hormones, inmunological markers, full blood count and hemostasis will be made. The patient will carry out dietary intervention and follow-up in each phase of the process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomization will be a simple one with Epidat 4.1. A number sequence will be carried out and it will be kept in opaque closed envelopes. The envelope will be opened the operation day and the surgery technique will be decided randomly, according to the randomization sequence.
| Arm | Type | Receives |
|---|---|---|
| Gastric bypass | Active comparator | Procedure: metabolic surgeryTwenty patients will be randomly assigned to perform a laparoscopic gastric bypass. |
| Slevee gastrectomy | Active comparator | Procedure: metabolic surgeryTwenty patients will be randomly assigned to perform a sleeve gastrectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both sex patients aged between 18 and 65 years old
- Class I obesity (BMI 30-35 kg/m2) with bad metabolic control (DM-2 with HbA1c > 7,5%) and non-insulin anti-diabetic treatment failure (it is necessary >10 years of known diabetes evolution time, C-peptide≥ 1 ng/ml, no insulin treatment, at least two oral hypoglycemic agents treatment);
- Patients who accomplish the follow-up protocol designed by both Surgery and Endocrinology departments
- Informed consent signed
Key exclusion criteria (2 listed)
- Patients who do not accomplish the previosly described inclusion criteria; Patient's refusal to take part in the study; Patients with symptomatology of gastroesophageal reflux disease or with upper gastrointestinal series compatible with this desease.
- Previous bariatric surgery
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 |
|---|---|---|
| metabolic surgeryThe study will randomize patients into two arms, one where a laparoscopic gastric bypass will be performed and another that will perform slevee gastrectomy. | Procedure or surgery | Gastric bypass, Slevee gastrectomy |
Primary outcome
Number of participans with normal glycosylated hemoglobin levels
Time frame: 1 year after surgery
Healing will be defined when HbA1c and fasting glycaemia levels are inside normal limits (Hb1Ac < 6%, FBG<100mg/dl) without needing oral hypoglycemic agents.
4 secondary outcomes
Number of participants with partial remission or improvement of diabetes
Time frame: 1 year after surgery
Comparison of weight loss between the two techniques; bypass and sleeve.
Time frame: 2 years after surgery
Evaluation of postoperative complications in patients undergoing bypass and slevee with Clavien-Dindo classification.
Time frame: 1 month after surgery
Comparison postoperative pain in sleeve and bypass with analogue assessment scale of postoperative pain.
Time frame: 3 days postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing metabolic surgery in people with Diabetes Mellitus and Metabolic Surgery, run by Hospital Universitario Doctor Peset at 1 site in Spain.
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 4 inclusion and 2 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 26 Mar 2019. 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 Spain. 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 Nuria Peris Tomás, PhD (0034 617019132, nuriapt27@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participans with normal glycosylated hemoglobin levels (time frame: 1 year after surgery). 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 26 Mar 2019.