NCT00957957

Brief Summary

This study will examine changes in various gut-derived hormones in obese type 2 diabetic patients before and after elective bariatric surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2010

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

August 11, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

4.8 years

First QC Date

August 11, 2009

Last Update Submit

January 19, 2016

Conditions

Obesity, MorbidDiabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in PYY (Peptide YY) measured by ELISA 4 weeks after RYGBP

    Baseline and Week 4

Secondary Outcomes (1)

  • Change from baseline in PYY measured by dMS 4 weeks after RYGBP

    Baseline and week 4

Study Arms (2)

1

Participants having elective Roux-en-Y gastric bypass surgery (RYGBP)

2

Participants having elective gastric banding surgery (GB)

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Morbidly obese type 2 diabetic patients

You may qualify if:

  • Documented type 2 diabetes with total disease duration ≤10 years
  • BMI of at least 35 kg/m\^2
  • Patient is a surgical candidate for either RYGBP, GBS or vertical sleeve gastrectomy (VSG)

You may not qualify if:

  • Any illness that might confound the results of the study or pose additional risk to the patient by participation
  • History of stroke, seizures, or other major neurological disorder
  • History of cancer
  • Patient uses or has used any medication that can alter body weight
  • Patient is unwilling or unable to follow study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Shankar SS, Mixson LA, Chakravarthy M, Chisholm R, Acton AJ, Jones R, Mattar SG, Miller DL, Petry L, Beals CR, Stoch SA, Kelley DE, Considine RV. Metabolic improvements following Roux-en-Y surgery assessed by solid meal test in subjects with short duration type 2 diabetes. BMC Obes. 2017 Mar 1;4:10. doi: 10.1186/s40608-017-0149-1. eCollection 2017.

    PMID: 28265415DERIVED

MeSH Terms

Conditions

Obesity, MorbidDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2009

First Posted

August 13, 2009

Study Start

February 1, 2010

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

January 20, 2016

Record last verified: 2016-01