NCT01848795

Brief Summary

Obese patients with Type 2 diabetes (T2D) have a 80-98% chance of having their disease cured or improved following bariatric surgery. This could be explained by weight loss or by changes of nutrient absorption or gut hormone secretion. The comparison of glucose metabolism in patients undergoing malabsorptive or mechanical procedures will clarify this matter. EndoBarrier is an endoscopically delivered device that mimics malabsorptive surgical procedures while the endoscopically placed intragastric balloon induces weight loss with a mechanical action. The present study hypothesis is that the bypass of the first portion of the intestine obtained with the EndoBarrier will be more effective in improving glucose metabolism than the reduction of food intake obtained with the intragastric balloon. Since similar weight loss is expected in the two groups, the study will aid in understanding the mechanisms behind the metabolic improvement seeing after intestine bypass.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes

Timeline
Completed

Started May 2013

Longer than P75 for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 8, 2013

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

6 years

First QC Date

May 3, 2013

Last Update Submit

March 23, 2015

Conditions

Type 2 DiabetesObesity

Keywords

Type 2 DiabetesObesitygastrointestinal hormonesintestinal bypassendoscopy

Outcome Measures

Primary Outcomes (1)

  • Glycated hemoglobin

    measurement of diabetes metabolic control

    12 months

Study Arms (2)

EndoBarrier Gastrointestinal Liner

EXPERIMENTAL

The treatment in this arm is the endoscopic positioning of the EndoBarrier Gastrointestinal Liner and follow up.

Device: EndoBarrier Gastrointestinal Liner

Intragastric Balloon

ACTIVE COMPARATOR

The treatment in this arm is the endoscopic positioning of the intragastric balloon (Easy life balloon) as a comparator and follow up.

Device: Easy life balloon

Interventions

EndoBarrier Gastrointestinal LinerDEVICE

Endoscopy placement of EndoBarrier, and clinical and biochemical follow up

Also known as: produced by GI Dynamics
EndoBarrier Gastrointestinal Liner
Easy life balloonDEVICE

Endoscopy placement of EndoBarrier, and clinical and biochemical follow up

Intragastric Balloon

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults (18-60 year old)
  • Type 2 Diabetes diagnosed less than 10 years ago
  • Obesity (BMI \> 30)

You may not qualify if:

  • pregnancy
  • inflammatory bowel disease
  • peptic ulcer
  • gastrointestinal disease preventing device positioning
  • pancreatitis,
  • coronary artery disease
  • symptomatic pulmonary disease
  • infection at the time of device placement,
  • high risk of gastrointestinal bleeding (coagulopathy, bleeding diathesis, anti-coagulant therapy, Non-Steroid Anti-Inflammatory Drugs)
  • altered GI anatomy that could affect device placement
  • contraindication of positioning of the devices as per technical description of the producer
  • C-peptide negative diabetes
  • failure to understand the study protocol or not willing to undergo planned follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ISMETT

Palermo, Italy, 90127, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anna Casu, MD

    The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Casu, MD

CONTACT

+390912192111acasu@ismett.edu

Mario Traina, MD

CONTACT

+390912192111mtraina@ismett.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Diabetology Attending

Study Record Dates

First Submitted

May 3, 2013

First Posted

May 8, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

March 24, 2015

Record last verified: 2015-03

Locations

IT(1)