Status:
RECRUITING
Effect of Meal Composition and Timing Modification on Glucose Metabolism, Body Temperature and Sleep
Lead Sponsor:
Stanford University
Conditions:
PreDiabetes
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of our study is to understand the impact of different meal timing alterations on blood sugars, metabolism, microbiome and sleep physiology in people with prediabetes and diabetes; and to s...
Detailed Description
Pilot data points to an effect of the time between waking up and first meal is important in blood glucose management through the rest of the day. The investigators are interested in understanding the ...
Eligibility Criteria
Inclusion
- Be 18 years of age or older;
- Not be pregnant, if female;
- Be generally healthy (with no apparent symptoms at the time of enrollment)
- Patients with prediabetes or diet- controlled or type 2 diabetes or controlled with metformin, will also be allowed to participate.
- Be willing to provide written informed consent for all study procedures.
Exclusion
- major organ disease
- pregnant/lactating
- diabetes medications except for metformin
- malabsorptive disorders like celiac sprue
- heavy alcohol use
- use of weight loss medications or specific diets
- weight change \>2 Kg in the last month
- history of bariatric surgery
- Any medical condition that physicians believe would interfere with study participation or evaluation of results
- Mental incapacity and/or cognitive impairment on the part of the patient that would preclude adequate understanding of, or cooperation with, the study protocol.
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05413928
Start Date
February 1 2023
End Date
December 1 2025
Last Update
December 2 2024
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94304