MedDataX Logo

Diabetes Resolution and Hormone Changes After BPDLL and LSG

NCT ID: NCT01481675

Last Updated: 2011-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate and compare prospectively the effects of Biliopancreatic Diversion Long Limb (BPDLL) and Laparoscopic Sleeve Gastrectomy (LSG) on resolution of diabetes mellitus type 2.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Twelve patients with diabetes mellitus type 2 (DM 2) and body mass index (BMI)\> 50kg/m2) will undergo BPDLL and 12 twelve patients with DM 2 and BMI 40-50 kg/m2 will undergo LSG. The patients will be evaluated before and 1, 3 and 12 months after surgery with an oral glucose tolerance test. The investigators aim to investigate the effects of surgery on diabetes resolution, hypertension, dyslipidemia, and also on fasting, and glucose-stimulated insulin, glucagon, ghrelin, peptide-YY and glucagon-like peptide-1 (GLP-1) responses during during an oral glucose tolerance test (OGTT). Resolution of diabetes mellitus will be evaluated according to the criteria of American Diabetes Association with an OGTT. The effects on appetite and satiety will be also evaluated with the use of visual analog scores.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

biliopancreatic diversion sleeve gastrectomy diabetes mellitus weight loss ghrelin PYY GLP-1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BPDLL group

Patients subjected to the Biliopancreatic Diversion Long Limbs surgical operation will undergo an oral glucose tolerance preoperatively and 12 months after the operation

No interventions assigned to this group

LSG group

Patients subjected to laparoscopic sleeve gastrectomy will undergo an oral glucose tolerance test preoperatively and 12 months postoperatively

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* BMI\>50kg/m2 to undergo BPDLL
* BMI 40-50kg/m2 to undergo LSG
* Diabetes mellitus type 2

Exclusion Criteria

* Chronic medical illness
* Psychiatric illness
* Substance abuse
* Previous gastrointestinal surgery
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Patras

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Theodore K. Alexandrides

Professor of Medicine, Head of Endocrine Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Theodore Alexandrides, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Patras

Fotis Kalfarentzos, Professor

Role: STUDY_DIRECTOR

University of Patras

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital of Patras

Rio, Achaia, Greece

Site Status

University Hospital of Patras

Rio, Achaia, Greece

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Greece

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BPDLL vs LSG

Identifier Type: OTHER

Identifier Source: secondary_id

BPDLSG002

Identifier Type: -

Identifier Source: org_study_id