NCT01652105

Brief Summary

Randomized clinical trial of two preoperative diets before bariatric surgery (gastric bypass)comparing standard diet and Prodimed (VLCD) in 100 morbidly obese patients selected for a gastric bypass procedure

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

July 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

August 7, 2012

Status Verified

August 1, 2012

Enrollment Period

6 months

First QC Date

July 25, 2012

Last Update Submit

August 6, 2012

Conditions

Morbid ObesityBariatric SurgeryGastric Bypass

Keywords

Gastric bypassPreoperative dietProdimed

Outcome Measures

Primary Outcomes (1)

  • Preoperative weight loss before bariatric surgery

    Weight loss in kg before operation

    2 weeks

Secondary Outcomes (1)

  • - operation time - blood loss - difficulty of procedure - short term complications - acceptance of diets according to patients

    2 weeks

Study Arms (2)

Diet

EXPERIMENTAL

New developed diet

Dietary Supplement: Standard diet versus standard VLCD (Prodimed)

Prodimed

ACTIVE COMPARATOR

Standard VLCD

Dietary Supplement: Standard diet versus standard VLCD (Prodimed)

Interventions

Standard diet versus standard VLCD (Prodimed)DIETARY_SUPPLEMENT
DietProdimed

Eligibility Criteria

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

You may qualify if:

  • morbid obesity according to IFSO criteria

You may not qualify if:

  • previous bariatric or gastric surgery
  • severe psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bariatric Centre Lievensberg hospital

Bergen op Zoom, 4624 VT, Netherlands

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ruben Schouten, Md, PhD

CONTACT

schoutenruben@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 25, 2012

First Posted

July 27, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2013

Study Completion

June 1, 2013

Last Updated

August 7, 2012

Record last verified: 2012-08

Locations

NL(1)