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New treatment option for PreDiabetes
Official title Dinner Time for Obesity and Prediabetes
ClinicalTrials.gov ID: NCT05745441
What this study is testing
What is Early Dinner tracer?
Early Dinner tracer is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for prediabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- The investigators are enrolling both Normal-Weight Healthy (NWH) and Obesity-Prediabetes (OPD) research participants.
- 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.
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- The investigators are enrolling both Normal-Weight Healthy (NWH) and Obesity-Prediabetes (OPD) research participants.
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.