NCT00948545

Brief Summary

In the proposed study, the investigators will explore three specific aims. First, the investigators will examine cross-sectionally the association of obesity on sympathetic, parasympathetic, and sympathetic/ parasympathetic nerve fiber balance. In addition, the investigators will determine the relationship of the ANS and osteocalcin. Osteocalcin will be measured before and after a mixed meal tolerance test. In the second specific aim, the investigators will prospectively follow-up these individuals (n=30) following bariatric surgery. The effect of weight loss on measures of the ANS and osteocalcin will be examined 6 months following surgery with participants serving as their own control, pre- and post-surgical intervention. Thirdly, the investigators will address whether the effect of weight loss on the ANS and osteocalcin differ between those who had a history of diabetes at baseline versus those with no history of diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

November 7, 2012

Status Verified

November 1, 2012

Enrollment Period

1.9 years

First QC Date

July 28, 2009

Last Update Submit

November 6, 2012

Conditions

Bariatric Surgery

Keywords

Autonomic nervous systemBariatric surgeryObservational study for individuals having bariatric surgery

Outcome Measures

Primary Outcomes (1)

  • To determine the association of obesity on sympathetic, parasympathetic, and sympathetic/parasympathetic nerve fiber balance and to determine the relationship of the ANS and osteocalcin.

    2 years

Secondary Outcomes (1)

  • To determine the effect of weight loss on measures of the ANS and determinants of insulin sensitivity (e.g., osteocalcin) 6 months following surgery with participants serving as their own control, pre- and post-surgical intervention.

    2 years

Study Arms (1)

No treatment

Observing individuals pre and post bariatric surgery

Other: Observational study - there is no intervention

Interventions

Observational study - there is no interventionOTHER

Observational study - there is no intervention

No treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Individuals having bariatric surgery

You may qualify if:

  • Individuals aged 18 - 60 years old.
  • Individuals with a BMI \> 35 kg/m2.
  • Patients that have enrolled in a program to undergo weight loss by Roux-en-Y gastric bypass and having passed the pre-operative clearance program.
  • Individuals with diabetes who are currently being treated with diet, exercise, and/or oral medications will be included.

You may not qualify if:

  • Patients that have had previous gastric surgery, including but not limited to pancreobiliary diversion, vertical banded gastroplasty, and jejunoileostomy.
  • Individuals with known coronary artery disease (e.g., post-MI), atrial fibrillation,frequent atrial arrhythmias, frequent ventricular arrhythmias, a pacemaker, or myocardial ischemia.
  • Individuals taking the following medications that may affect the autonomic nervous system: anti- tuberculosis drugs, nitrofurantoin, metronidazole, chloramphenicol,perhexiline maleate, amiodarone, clofibrate, tricyclic antidepressants, phenytoin,methotrexate, barbiturates, neuroleptic drugs, antiparkinsonism drugs, fluoxetine, and nitrated drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma, urine

Study Officials

  • M James Lenhard, MD

    Christiana Care Health Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2009

First Posted

July 29, 2009

Study Start

July 1, 2009

Primary Completion

June 1, 2011

Study Completion

April 1, 2012

Last Updated

November 7, 2012

Record last verified: 2012-11

Locations

US(1)