RECRUITING

Dinner Time for Obesity and Prediabetes

Conditions

PreDiabetes Obesity Healthy circadian sleep glucose metabolism

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Obesity and its metabolic complications are leading causes of global morbidity and mortality. Evidence is mounting that inappropriate timing of food intake contributes to obesity. Specifically, late eating is associated with greater weight gain and metabolic syndrome. However, the mechanism by which late eating harms metabolism is not fully understood but may be related to mis-timing of food intake in relation to the body's endogenous circadian rhythm. Conversely, harmonization of eating timing with endogenous circadian rhythm may optimize metabolic health. In this study the investigators will use gold-standard methods of characterizing circadian rhythm in humans to examine the metabolic impacts food timing relative to endogenous circadian rhythm.

Official Title

Dinner Time for Obesity and Prediabetes

Quick Facts

Study Start:2023-07-05

Study Completion:2027-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05745441

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* For the Normal-Weight Healthy (NWH) cohort: Healthy male and female adults, age 18-50, with BMI 18-24.9 kg/m2 inclusively * For the Obesity-Prediabetes (OPD) cohort: Male and female adults, age 18-50, with BMI ≥30 kg/m2 and prediabetes * All participants must be able to understand study procedures, to comply with the procedures for the entire length of the study and be fully mobile.	* Sleep disorder including insomnia, untreated moderate-severe sleep apnea, restless leg syndrome, or narcolepsy * Night shift work * Extreme delayed sleep phase defined as self-reported routine bedtime later than 1:00 AM or having mid-sleep on free days later than 5:00 AM on the Munich Chronotype Questionnaire (MCTQ) or DLMO later than 24:00 * Gastroesophageal reflux disease that affects ability to tolerate a dinner close to bedtime * Active smoking * Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. * Diabetes (type 1 or 2) or on any diabetes medications besides metformin * Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, thyroid disease) * Hemoglobin A1c ≥5.7% for NWH cohort; Hemoglobin A1c ≥6.5% for OPD cohort * Hemoglobin \< 10 g/dL * Self-reported kidney disease * Any known history of an inherited metabolic disorder * Pregnant or lactating female (pregnancy test will be required prior to metabolic visits) * Peri-menopausal or post-menopausal female as determined by follicle stimulating hormone of \> 30 mIU/mL or fewer than 3 menstrual periods in 6 months * Professional or collegiate athlete * Participants who have travelled across time zones must have adequate time to recover from jet lag prior to enrollment (i.e., at least 3 days per time zone). Travel across \>1 time zone after enrollment in the study will not be permitted. * Weight less than 40 kg or more than 180 kg * Gastrointestinal disorders that can lead to obstruction of the digestive tract (i.e. diverticular disease, history of bowel obstruction, inflammatory bowel disease, motility disorder) * History of any surgical procedures in the gastrointestinal tract. * Swallowing disorders * Taking any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, asthma medication, blood pressure medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team) * Chronic use of sedative hypnotics, anxiolytics, opiates * Use of medications that can affect circadian rhythm (beta blockers, melatonin) * Presence of a cardiac pacemaker or other implanted electro-medical devices * Those who have to undergo strong electromagnetic field during the period of use of the ingestible thermosensor (i.e. MRI) * Weight loss or gain of ≥ 5% of total body weight over the preceding 3 months * Currently participating in a weight loss program * Prior bariatric surgery * Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies) * History of significant intravenous access issues * Non-English speaking individuals: The complexity of the instructions for various components of the study would make the study procedures difficult to follow in the setting of a language barrier. * Other conditions or situations at the discretion of the PI

Inclusion Criteria

Exclusion Criteria

* For the Normal-Weight Healthy (NWH) cohort: Healthy male and female adults, age 18-50, with BMI 18-24.9 kg/m2 inclusively
* For the Obesity-Prediabetes (OPD) cohort: Male and female adults, age 18-50, with BMI ≥30 kg/m2 and prediabetes
* All participants must be able to understand study procedures, to comply with the procedures for the entire length of the study and be fully mobile.

* Sleep disorder including insomnia, untreated moderate-severe sleep apnea, restless leg syndrome, or narcolepsy
* Night shift work
* Extreme delayed sleep phase defined as self-reported routine bedtime later than 1:00 AM or having mid-sleep on free days later than 5:00 AM on the Munich Chronotype Questionnaire (MCTQ) or DLMO later than 24:00
* Gastroesophageal reflux disease that affects ability to tolerate a dinner close to bedtime
* Active smoking
* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Diabetes (type 1 or 2) or on any diabetes medications besides metformin
* Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, thyroid disease)
* Hemoglobin A1c ≥5.7% for NWH cohort; Hemoglobin A1c ≥6.5% for OPD cohort
* Hemoglobin \< 10 g/dL
* Self-reported kidney disease
* Any known history of an inherited metabolic disorder
* Pregnant or lactating female (pregnancy test will be required prior to metabolic visits)
* Peri-menopausal or post-menopausal female as determined by follicle stimulating hormone of \> 30 mIU/mL or fewer than 3 menstrual periods in 6 months
* Professional or collegiate athlete
* Participants who have travelled across time zones must have adequate time to recover from jet lag prior to enrollment (i.e., at least 3 days per time zone). Travel across \>1 time zone after enrollment in the study will not be permitted.
* Weight less than 40 kg or more than 180 kg
* Gastrointestinal disorders that can lead to obstruction of the digestive tract (i.e. diverticular disease, history of bowel obstruction, inflammatory bowel disease, motility disorder)
* History of any surgical procedures in the gastrointestinal tract.
* Swallowing disorders
* Taking any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, asthma medication, blood pressure medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team)
* Chronic use of sedative hypnotics, anxiolytics, opiates
* Use of medications that can affect circadian rhythm (beta blockers, melatonin)
* Presence of a cardiac pacemaker or other implanted electro-medical devices
* Those who have to undergo strong electromagnetic field during the period of use of the ingestible thermosensor (i.e. MRI)
* Weight loss or gain of ≥ 5% of total body weight over the preceding 3 months
* Currently participating in a weight loss program
* Prior bariatric surgery
* Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies)
* History of significant intravenous access issues
* Non-English speaking individuals: The complexity of the instructions for various components of the study would make the study procedures difficult to follow in the setting of a language barrier.
* Other conditions or situations at the discretion of the PI

Contacts and Locations

Study Contact

Athena Mavronis

CONTACT

(410) 550-4588

amavron1@jhmi.edu

Mariah Potocki

CONTACT

410-550-2233

mchaney7@jhmi.edu

Principal Investigator

Jonathan Jun, MD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Stephanie T Chung, MBBS

PRINCIPAL_INVESTIGATOR

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Locations (Sites)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224

United States

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Jonathan Jun, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University
Stephanie T Chung, MBBS, PRINCIPAL_INVESTIGATOR, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-05

Study Completion Date2027-06-30

Study Record Updates

Study Start Date2023-07-05

Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

circadian
sleep
glucose
metabolism

Additional Relevant MeSH Terms

PreDiabetes
Obesity
Healthy