Randomized Study of the Effects of Glucose on Cognition i... | NCT00004451

Studies
Randomized Study of the Effects of Glucose on Cognition in Healthy Young and Elderly People and Parkinson's Disease Patients

NCT00004451

Sponsor

National Institute of Mental Health (NIMH)

Status

Completed

Last Update Posted

Dec 1, 2005Estimated

Enrollment

120

Phase

Not Applicable

Conditions

Parkinson Disease

Interventions

Glucose

Countries

United States

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
K07MH001197	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Nov 2005

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

Mar 1998

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 18, 1999

First Submission Date that Met QC Criteria

Oct 18, 1999

First Posted Date

Oct 19, 1999Estimated

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

Nov 29, 2005

Last Update Posted Date

Dec 1, 2005Estimated

Name	Class
University of Virginia	OTHER

Description Module

Brief Summary

This study will determine whether glucose facilitates memory in healthy elderly people and those with Parkinson's disease.

Detailed Description

Subjects fast for 8 hours before receiving a test to determine their blood glucose levels. Following this test, subjects are randomized to receive either a glucose or saccharin sweetened drink. A series of memory tests and an additional 3 blood glucose level tests are administered approximately 15 minutes later. A minimum of 1 week afterward, the subjects return and receive the alternate sweetener followed by additional memory tests.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120

Name	Type	Description	Arm Group Labels	Other Names
Glucose	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Three groups of subjects are eligible for this study: Healthy young adults between ages 18 and 30; Healthy elderly adults between ages 60 and 90; AND Anyone diagnosed with Parkinson's disease

Exclusion Criteria:

Prior surgery to remove part of the stomach
Diabetes, Addison's, or Cushing's diseases

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carol A. Manning	University of Virginia	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Virginia		Charlottesville	Virginia	22908	United States

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease
D009461	Neurologic Manifestations
D001523	Mental Disorders
D035583	Rare Diseases

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005947	Glucose

Ancestor Terms

ID	Term
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided