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Protocol Details

Dinner Time for Obesity and Prediabetes (DTOP)

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000911-DK

Sponsoring Institute

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

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 50 Years

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Food Intake;
Fat Oxidation;
CIRCADIAN RHYTHMS;
Dim Light Melatonin Onset (Dlmo);
Metabolic Dysfunction

Recruitment Keyword(s)

None

Condition(s)

Obesity;
Type 2 Diabetes (T2dm)

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Other: Early Dinner (ED)
Other: Late Dinner (LD)

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

Background:

Studies suggest that eating late at night is linked with obesity; however, these studies do not account for differences in people s internal clocks. Researchers want to learn more.

Objective:

To study how eating at different times, relative to a person s internal clock, affects metabolism.

Eligibility:

People aged 18 to 50 years. Two groups are needed: people who are obese and have prediabetes, and people who have a normal weight and are healthy.

Design:

Participants will have one overnight stay at Johns Hopkins University (JHU) and two 2-night stays at the National Institutes of Health (NIH).

One week before each overnight visit, participants will wear a device like a wristwatch to monitor their activities. They will keep diaries of their food and sleep. They will wear a sensor on their skin to monitor their blood sugar levels. Before the NIH visits, they will be asked to sleep at certain times.

At JHU, participants will swallow a pill-sized thermometer. They will sit still in dim lighting for up to 10 hours; saliva will be collected every 30 minutes. They will lie under a plastic dome to measure how much oxygen they use as they breathe.

At NIH, participants will stay in a special room that monitors the oxygen they inhale and the carbon dioxide they exhale. Lights will be turned on and off and meals will be delivered on a set schedule. They will have a thin tube placed in a vein in the arm for drawing blood.

The NIH stay will be repeated after 3 to 4 weeks. The sleep and meal schedules will be different at each visit.

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Eligibility

INCLUSION CRITERIA:

Participants must meet all of the inclusion criteria to participate in this study.

-Normal-weight healthy (NWH) cohort:

--Healthy male and female adults, age 18-50

--BMI 18-24.9 kg/m2

-Obesity-Prediabetes (OPD) cohort:

--Male and female adults, age 18-50

--BMI >=30 kg/m2

--Prediabetes defined by hemoglobin A1c 5.7-6.4% or fasting glucose from 100 to 125 mg/dL or 2-hour glucose from 140 to 199 mg/dL after 75-gram oral glucose tolerance test

-All participants must be able to understand study procedures, to comply with them for the entire length of the study and be fully mobile.

EXCLUSION CRITERIA:

All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation.

-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 1:00AM or having mid-sleep on free days later than 5:00AM 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 (may interfere with metabolism and CRU activities)

-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)

-HbA1c point of care >=5.7% for NWH cohort; HbA1c point of care >=6.5% for OP cohort

-Point-of-care 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

-Travel across >1 time zone within a 3-month period before and during the protocol

-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


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Stephanie T. Chung, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIHBC 10 - CRC BG RM 5-5940
10 CENTER DR
BETHESDA MD 20892
(240) 479-8137
stephanie.chung@nih.gov

Lilian S. Mabundo
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health
Building 10
Room 5-5750
10 Center Drive
Bethesda, Maryland 20892
(240) 383-9379
lilian.mabundo@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT05745441

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