Gut Hormone Profiling in Obese Patients With Type 2 Diabe... | NCT00957957

Studies
Gut Hormone Profiling in Obese Patients With Type 2 Diabetes (MK-0000-134)

NCT00957957

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Jan 20, 2016Estimated

Enrollment

22Actual

Phase

Not provided

Conditions

Obesity, Morbid
Diabetes Mellitus Type 2

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009_002	Other Identifier	Merck

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Nov 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Aug 11, 2009

First Submission Date that Met QC Criteria

Aug 12, 2009

First Posted Date

Aug 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2016

Last Update Posted Date

Jan 20, 2016Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Participants having elective Roux-en-Y gastric bypass surgery (RYGBP)
2		Participants having elective gastric banding surgery (GB)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in PYY (Peptide YY) measured by ELISA 4 weeks after RYGBP		Baseline and Week 4

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in PYY measured by dMS 4 weeks after RYGBP		Baseline and week 4

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Morbidly obese type 2 diabetic patients

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28265415	Derived	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.

ID	Term
D009767	Obesity, Morbid
D003924	Diabetes Mellitus, Type 2

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders