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Completed

NCT Number: NCT04595396

Laparoscopic Gastric Bypass as Metabolic Surgery in Obesity Class 1

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).

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Key information

Conditions

Type2 Diabetes Bariatric Surgery Candidate Body Weight Laparoscopic Gastric Bypass Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General Tlahuac

Mexico City, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic gastric bypass

Procedure

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

Other names: Roux-en-y gastric bypass

Primary outcomes

  1. Weight Loss

    Time frame: 12 months

    Measure: weight (kilograms)

  2. Weight Loss

    Time frame: 24 months

    Measure: weight (kilograms)

  3. Weight Loss

    Time frame: 36 months

    Measure: weight (kilograms)

  4. Weight Loss

    Time frame: 12 months

    Measure: Body Mass Index

  5. Weight Loss

    Time frame: 24 months

    Measure: Body Mass Index

  6. Weight Loss

    Time frame: 36 months

    Measure: Body Mass Index

  7. Weight Loss

    Time frame: 12 months

    Measure: % excess weight loss

  8. Weight Loss

    Time frame: 24 months

    Measure: % excess weight loss

  9. Weight Loss

    Time frame: 36 months

    Measure: % excess weight loss

  10. Weight Loss

    Time frame: 12 months

    Measure: % total weight loss

  11. Weight Loss

    Time frame: 24 months

    Measure: % total weight loss

  12. Weight Loss

    Time frame: 36 months

    Measure: % total weight loss

Secondary outcomes

  1. Complete Diabetes Remission

    Time frame: 12 months

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

  2. Complete Diabetes Remission

    Time frame: 24 months

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

  3. Complete Diabetes Remission

    Time frame: 36 months

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

  4. Late complications

    Time frame: After 30 days from surgery

    Complications requiring re-admssion / re-operation

  5. Early complications

    Time frame: First 30 days after surgery

    Complications requiring re-admssion / re-operation

Sponsors and collaborators

Lead sponsor

CARLOS ZERRWECK LOPEZ

Other Gov

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Oct 20, 2020
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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