This study is currently recruiting participants.
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)
Condition(s)
Obesity; Type 2 Diabetes (T2dm)
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Other: Early Dinner (ED) Other: Late Dinner (LD)
Supporting Site
National Institute of Diabetes and Digestive and Kidney Diseases
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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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
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
Principal Investigator
Referral Contact
For more information: