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Type2 DiabetesNCT04595396

Laparoscopic Gastric Bypass as Metabolic Surgery in Obesity Class 1

An observational study of Type2 Diabetes and Bariatric Surgery Candidate, run by CARLOS ZERRWECK LOPEZ at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Prospective study including Mexican patients diagnosed with type 2 diabetes and class 1 obesity, undergoing laparoscopic gastric bypass. The objective was to determine short, mid-and long-term outcomes (weight loss, metabolic, morbidity and diabetes remission). Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Laparoscopic Gastric Bypass
Type of treatment
Surgery or procedure
How many people
51 participants
Where
1 siteMexico
Study dates
1 Sep 2012to 31 Dec 2019
Phase
Observational
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Mexican patients with T2DM submitted to laparoscopic gastric bypass

Inclusion criteria Any sex >18 years-old <60 years-old Class 1 obesity (BMI 30-34.9 kg/m2) Type-2 diabetes mellitus diagnosis (with or without medication) Submitted to laparoscopic gastric bypass

Exclusion criteria Other bariatric surgery Revisional surgery Incomplete charts

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Hospital General Tlahuac

    Mexico City

Other trials in Mexico

About this study

Official title: Gastric Bypass as Metabolic Surgery in Obesity Class 1: a Prospective Study of the Short, Mid and Long Term Results Among Mexicans

Prospective study including Mexican patients diagnosed with type 2 diabetes and class 1 obesity, undergoing laparoscopic gastric bypass. The objective was to determine short, mid-and long-term outcomes (weight loss, metabolic, morbidity and diabetes remission). A subanalysis was included, based on preoperative usage of one (Group A) or more antidiabetics ± insulin (Group B).

Being tested
Laparoscopic Gastric Bypass
Keywords
bariatric surgery, obesity class 1, metabolic surgery, laparoscopic gastric bypass, type-2 diabetes mellitus
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic Gastric BypassProcedure or surgery

    Also called Roux-en-y gastric bypass

    The LGBP was performed using a classic Roux-en-Y procedure. Briefly, a gastric pouch of 30-50 cc was constructed with an antecolic calibrated gastro-jejunal anastomosis (mechanical anastomosis using a 2.5 mm load). The biliary and alimentary limbs measured ≈70 cm and ≈150 cm, respectively, and the jejuno-jejunal anastomosis was also performed in a latero-lateral fashion (mechanical anastomosis using a 2.5 mm load). Mesenteric defects were closed with running non-absorbable sutures and the omentum was divided in every case

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight Loss

    Measure: weight (kilograms)

    Measured: 12 months

  2. Weight Loss

    Measure: weight (kilograms)

    Measured: 24 months

  3. Weight Loss

    Measure: weight (kilograms)

    Measured: 36 months

  4. Weight Loss

    Measure: Body Mass Index

    Measured: 12 months

  5. Weight Loss

    Measure: Body Mass Index

    Measured: 24 months

  6. Weight Loss

    Measure: Body Mass Index

    Measured: 36 months

  7. Weight Loss

    Measure: % excess weight loss

    Measured: 12 months

  8. Weight Loss

    Measure: % excess weight loss

    Measured: 24 months

  9. Weight Loss

    Measure: % excess weight loss

    Measured: 36 months

  10. Weight Loss

    Measure: % total weight loss

    Measured: 12 months

  11. Weight Loss

    Measure: % total weight loss

    Measured: 24 months

  12. Weight Loss

    Measure: % total weight loss

    Measured: 36 months

Secondary outcomes (5)

  1. Complete Diabetes Remission

    Definition: no antidiabetic drugs while on glucose <100 mg/dl and HbA1C% <6

    Measured: 12 months

  2. Complete Diabetes Remission

    Definition: no antidiabetic drugs while on glucose <100 mg/dl and HbA1C% <6

    Measured: 24 months

  3. Complete Diabetes Remission

    Definition: no antidiabetic drugs while on glucose <100 mg/dl and HbA1C% <6

    Measured: 36 months

  4. Late complications

    Complications requiring re-admssion / re-operation

    Measured: After 30 days from surgery

  5. Early complications

    Complications requiring re-admssion / re-operation

    Measured: First 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2020
  2. Study start1 Sep 2012
  3. Primary completion1 Jan 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04595396
Sponsor's protocol ID
CONBIOETICA09-CEI-001-20160404
Status last verified
Oct 2020
First submitted
13 Oct 2020
Last updated
20 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cevallos L, Rodriguez FM, Herrera A, Sepulveda EM, Donatini G, Guilbert L, Zerrweck C. Metabolic Surgery and Class 1 Obesity (< 35 kg/m2): a Prospective Study with Short-, Mid-, and Long-term Results Among Latinos. Obes Surg. 2021 Jun;31(6):2401-2409. doi: 10.1007/s11695-021-05275-3. Epub 2021 Feb 17.

    PubMed 33598844

Questions about this trial

What is this clinical trial studying?

An observational study of Type2 Diabetes and Bariatric Surgery Candidate, run by CARLOS ZERRWECK LOPEZ at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 20 Oct 2020. 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 Mexico. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight Loss (time frame: 12 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04595396, which also lists 1 linked publication.

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 20 Oct 2020.

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