NCT00341770

Brief Summary

Obesity is the consequence of an imbalance between energy intake and energy expenditure. Recent studies have suggested that the sympathetic nervous system (SNS) may be an important determinant of the rate of energy expenditure in man. Indirect assessments of the sympathetic nervous activity in Pima Indians have recently shown impaired SNS-mediated energy expenditure in this obesity-prone population. We plan to perform direct microelectrode nerve recording of the sympathetic innervation of the lower leg to directly assess SNS activity and examine its potential role in the regulation of metabolic rate and the development of obesity. Measurements will be performed in the basal state, in response to glucose feeding (75 g OGTT) and in response to glucose/insulin infusion. These studies also will help to disassociate the effect of insulin and glucose on the stimulation of SNS activity. Energy expenditure measurements will be performed over 24 hours in the respiratory chamber and for 2 1/2 hours before and during the euglycemic clamp. Results also will be used to determine possible racial differences between Pimas and Caucasians, since the risk for obesity is markedly different in these populations. To exclude the possibility of a "normal" SNS activity but with peripheral resistance to the action of norepineprine, we will perform adrenergic stimulation by isoproterenol to measure peripheral adrenergic sensitivity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 1991

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 1991

Completed
15.2 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2010

Completed
Last Updated

July 2, 2017

Status Verified

November 23, 2010

First QC Date

June 19, 2006

Last Update Submit

June 30, 2017

Conditions

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female Pima Indians, age 4 years old and older.
  • Male and female Caucasians, age 4 years old and older.
  • Offspring of Diabetic and Non-Diabetic mothers will be recruited.
  • Male and female monozygotic and dizygotic twins of any racial background between the ages of 4-7 will be considered for study.
  • Indian subjects will be recruited from the Gila River Indian Community.
  • Only children found in good health on the basis of the medical history and physical examination will be accepted into the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIDDK, Phoenix

Phoenix, Arizona, 85014, United States

Location

Related Publications (3)

  • Bray GA, York DA, Fisler JS. Experimental obesity: a homeostatic failure due to defective nutrient stimulation of the sympathetic nervous system. Vitam Horm. 1989;45:1-125. doi: 10.1016/s0083-6729(08)60393-3.

    PMID: 2688303BACKGROUND
  • Ravussin E, Lillioja S, Knowler WC, Christin L, Freymond D, Abbott WG, Boyce V, Howard BV, Bogardus C. Reduced rate of energy expenditure as a risk factor for body-weight gain. N Engl J Med. 1988 Feb 25;318(8):467-72. doi: 10.1056/NEJM198802253180802.

    PMID: 3340128BACKGROUND
  • O'Dea K, Esler M, Leonard P, Stockigt JR, Nestel P. Noradrenaline turnover during under- and over-eating in normal weight subjects. Metabolism. 1982 Sep;31(9):896-9. doi: 10.1016/0026-0495(82)90178-0.

    PMID: 7121260BACKGROUND

MeSH Terms

Conditions

Neurologic Manifestations

Condition Hierarchy (Ancestors)

Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

April 12, 1991

Study Completion

November 23, 2010

Last Updated

July 2, 2017

Record last verified: 2010-11-23

Locations