NCT02768506

Brief Summary

Patients with BMI over 40 or with BMI over 35 and comorbidities are offered SADI-S with a variable limb length between 250 cm and 300 cm or gastric bypass. Results on weight loss, comorbidities resolution, complications, re-operations, need of supplements are registered.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

1.7 years

First QC Date

May 8, 2016

Last Update Submit

May 8, 2016

Conditions

Morbid ObesityDiabetes

Keywords

obesity, malabsorption, gastric bypass, SADI-S

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    Excess weight loss percentage and total weight loss percentage in the first 5 years

    5 years

Secondary Outcomes (1)

  • Diabetes remission

    5 years

Study Arms (2)

Gastric bypass

Subjects submitted to gastric bypass

SADI-S

Subjects submitted to SADI-S

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Morbid obesity patients asking for surgery

You may qualify if:

  • Morbid obesity

You may not qualify if:

  • Drug addiction
  • Alcoholic
  • Neoplasms
  • Immunosuppression
  • Mental diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Liver biopsy

MeSH Terms

Conditions

Obesity, MorbidDiabetes MellitusObesityMalabsorption Syndromes

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MD

Study Record Dates

First Submitted

May 8, 2016

First Posted

May 11, 2016

Study Start

September 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 11, 2016

Record last verified: 2016-05

Locations

ES(1)