Diabetes MellitusMSSNCT02310555
Surgical Techniques in Diabetes Mellitus-II and Obesity. Metabolic Surgery Study (MSS)
A study testing Gastric bypass, Modified gastric bypass. and Slevee Gastrectomy in people with Diabetes Mellitus and Obesity, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
Trial summary
The aim of this study is to compare clinical and laboratory findings of three surgical techniques in metabolic surgery in patients with type II diabetes mellitus and obesity (BMI> 30). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Obesity
- What is being tested?
- Gastric bypass, Modified gastric bypass. and Slevee Gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2014to May 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 30-40
- Diabetes Mellitus type II less than 10 years of evolution.
- Anti-GAD, anti-pancreatic islets negative antibodies.
- C peptide normally between 0.9 and 4.
- Glycosylated hemoglobin greater than 6.5%.
- Less than 5 years of use insulin.
Who cannot join
- Cirrosis hepática.
- coagulopathies.
- Type 1 diabetes.
- HIV positive.
- Stomach or small intestine previous surgeries .
- Diseases of the exocrine pancreas: pancreatitis, pancreatectomy, neoplasia, cystic fibrosis, hemochromatosis.
- Endocrinopathies: acromegaly, glucagonoma, Cushing's syndrome, pheochromocytoma, hyperthyroidism, somatostatinoma, aldosteronoma.
- Genetic syndromes with diabetes.
Trial locations and contacts
1 site in 1 country.
Juan A. Luján Mompean, Ph D; Section chief contact
Pascual Parrilla Paricio, Ph D; Department head contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
Juan A. Luján, Ph D, 968369677
Juan A. Luján, Ph D
About this study
Official title: Prospective Randomised Study Comparing Surgical Techniques in Patients With Diabetes Mellitus-II And Obesity
The aim of this study is to compare clinical and laboratory findings of three surgical techniques in metabolic surgery in patients with type II diabetes mellitus and obesity (BMI> 30).
- Conditions
- Diabetes Mellitus, Obesity
- Being tested
- Gastric bypass, Modified gastric bypass., Slevee Gastrectomy
- Keywords
- Metabolic surgery
- Medical subject headings
- Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric bypassProcedure or surgery
Modified gastric bypass.Procedure or surgery
Slevee GastrectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Gastric bypass | Active comparator | classic Gastric bypass Receives: Procedure: Gastric bypass |
| Modified gastric bypass. | Active comparator | Modified gastric bypass. Resection body and fundus gastric Receives: Procedure: Modified gastric bypass. |
| Slevee Gastrectomy | Active comparator | Slevee Gastrectomy Receives: Procedure: Slevee Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission diabetes mellitus type II
- 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.
Measured: Durign two years
Secondary outcomes (3)
Weight loss
Measured: During two years
Adverse effects in the short term
We'll measure the number of patients with postoperative complications and the the degree of severity of Clavien- Dindo Classification
Measured: During three months since surgery
Adverse effects in the long term
We'll measure the number of patients with postoperative complications and the the degree of severity of Clavien- Dindo Classification
Measured: Since third month after surgery untiil two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2015 (estimated)
- Study completionMay 2016 (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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen de la Arrixaca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Lujan, Hospital Universitario Virgen de la Arrixaca
- Investigators
- Juan A. Luján Mompean, Ph D; Section chief, Principal investigator, Hospital Clínico Universitario Virgen Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310555
- Sponsor's protocol ID
- HCUVA-MSS-JL
- Acronym
- MSS
- Status last verified
- Dec 2014
- First submitted
- 26 Nov 2014
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Study Comparing Surgical Techniques in Patients With Diabetes Mellitus-II And Obesity
- ClinicalTrials.gov ID
- NCT02310555
- Acronym / sponsor ID
- MSS / HCUVA-MSS-JL
- Conditions
- Diabetes Mellitus, Obesity
- Keywords
- Metabolic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital Universitario Virgen de la ArrixacaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 8 Dec 2014 (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 aim of this study is to compare clinical and laboratory findings of three surgical techniques in metabolic surgery in patients with type II diabetes mellitus and obesity (BMI> 30).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gastric bypass | Active comparator | Procedure: Gastric bypassclassic Gastric bypass |
| Modified gastric bypass. | Active comparator | Procedure: Modified gastric bypass.Modified gastric bypass. Resection body and fundus gastric |
| Slevee Gastrectomy | Active comparator | Procedure: Slevee GastrectomySlevee Gastrectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BMI 30-40
- Diabetes Mellitus type II less than 10 years of evolution.
- Anti-GAD, anti-pancreatic islets negative antibodies.
- C peptide normally between 0.9 and 4.
- Glycosylated hemoglobin greater than 6.5%.
Key exclusion criteria (8 listed)
- Cirrosis hepática.
- coagulopathies.
- Type 1 diabetes.
- HIV positive.
- Stomach or small intestine previous surgeries .
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 |
|---|---|---|
| Gastric bypass | Procedure or surgery | Gastric bypass |
| Modified gastric bypass. | Procedure or surgery | Modified gastric bypass. |
| Slevee Gastrectomy | Procedure or surgery | Slevee Gastrectomy |
Primary outcome
Remission diabetes mellitus type II
Time frame: Durign two years
1. 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. 2. Complete remission: Normal HbA1c (<6%); basal glucose <100 mg / dl (<5.6 mmol / l); Absence of drug treatment; At least one year. 3. Prolonged remission: At least 5 years of remission. 4. Improvement: HbA1c <7% with pharmacological treatment.
3 secondary outcomes
Weight loss
Time frame: During two years
Adverse effects in the short term
Time frame: During three months since surgery
Adverse effects in the long term
Time frame: Since third month after surgery untiil two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
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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.
Juan A. Luján Mompean, Ph D; Section chief contact
Pascual Parrilla Paricio, Ph D; Department head contact
Juan A. Luján Mompean, Ph D; Section chief principal investigator
Hospital Clínico Universitario Virgen Arrixaca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric bypass, Modified gastric bypass. and Slevee Gastrectomy in people with Diabetes Mellitus and Obesity, run by Hospital Universitario Virgen de la Arrixaca 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 6 inclusion and 8 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 8 Dec 2014. 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 Juan A. Luján Mompean, Ph D; Section chief (968369677), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission diabetes mellitus type II (time frame: Durign two years). 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 8 Dec 2014.