GLADS: Glucose, Activity, Diet, & Sleep Assessment Study

• Sponsor: Columbia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05139264
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Actual Duration (Months): 9
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolism Disorder, Glucose	Other: Observational

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 14 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: GLADS Study: Glucose, Activity, Diet, & Sleep Assessment Study
• Actual Study Start Date: May 3, 2021
• Actual Primary Completion Date: Feb 1, 2022
• Actual Study Completion Date: Feb 1, 2022

Outcome Measures

Primary Outcome Measures

1. Glucose [2 weeks]

   Mean, fasting, post-prandial measured by continuous glucose monitoring

Secondary Outcome Measures

1. Sleep duration [2 weeks]

   Measured by actigraphy

2. Sleep fragmentation [2 weeks]

   Measured by actigraphy

3. Diet composition [2 weeks]

   Carbohydrates, fats, proteins assessed by dietary recall

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Russ Berrie Medical Science Pavilion	New York	New York	United States	10032

Sponsors and Collaborators

• Columbia University

Investigators

• Principal Investigator: Blandine Laferrere, MD, PhD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Blandine Laferrere, Professor of Medicine, Columbia University
• ClinicalTrials.gov Identifier: NCT05139264
• Other Study ID Numbers: AAAT6779
• First Posted: Dec 1, 2021
• Last Update Posted: Feb 3, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Metabolic Diseases; Glucose Metabolism Disorders

Study Results

No Results Posted as of Feb 3, 2022