Glucose, Activity, Diet, & Sleep Assessment Study | NCT05139264

Studies
Glucose, Activity, Diet, & Sleep Assessment Study

NCT05139264

Sponsor

Columbia University

Status

Completed

Last Update Posted

Sep 21, 2023Actual

Enrollment

14Actual

Phase

Not provided

Conditions

Metabolism Disorder, Glucose

Interventions

Observational

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

Status Module

Record Verification Date

Sep 2023

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

May 3, 2021Actual

Primary Completion Date

Feb 1, 2022Actual

Completion Date

Feb 1, 2022Actual

First Submitted Date

Nov 18, 2021

First Submission Date that Met QC Criteria

Nov 18, 2021

First Posted Date

Dec 1, 2021Actual

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

Sep 18, 2023

Last Update Posted Date

Sep 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

GLADS is a cross-sectional, observational study assessing free-living diet, physical activity, sleep, and glucose profile over a 2-week period in healthy adult men and women.

Detailed Description

Monitoring free-living lifestyle behaviors can provide important information on behavioral determinants of health. New technologies have improved accessibility of ambulatory assessment of diet, biomarkers, physical activity, and sleep. The study will assess the effects of free-living diet assessed by questionnaire and sleep and physical activity measured by actigraphy on interstitial glucose measured by continuous glucose monitoring in healthy adult men and women over a 2-week period.

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

14Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational	Other	Observation of diet, physical activity, sleep and interstitial glucose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Glucose	Mean, fasting, post-prandial measured by continuous glucose monitoring	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Sleep duration	Measured by actigraphy	2 weeks
Sleep fragmentation	Measured by actigraphy	2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: 18-75 y old
In possession of a smartphone
English speaking
Live in New York City metro area

Exclusion Criteria:

Active food intake disorder

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Adult men and women willing to record food intake with their smartphone, complete online questionnaires, and wear body sensors to measure physical activity, sleep, and glucose.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Blandine Laferrere, MD, PhD	Columbia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Russ Berrie Medical Science Pavilion		New York	New York	10032	United States

Condition Browse Module

MeSH Terms

ID	Term
D044882	Glucose Metabolism Disorders

Ancestor Terms

ID	Term
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D057832	Watchful Waiting

Ancestor Terms

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided