Эта страница была переведена автоматически, точность перевода не гарантируется. Пожалуйста, обратитесь к английской версии для исходного текста.

Evaluating Metabolic Health in Individuals With Extreme Obesity

26 мая 2026 г. обновлено: Christian Rodriguez, Pennington Biomedical Research Center

Evaluating Energy Metabolism and Metabolic Health in Individuals With Extreme Obesity

This research will evaluate energy metabolism (expenditure and fat oxidation), metabolic flexibility (response to a high-fat test meal) in 10 individuals with a BMI ≥60 kgm2 using gold-standard assessments of energy metabolism, metabolic flexibility, and body composition. Males and females (18-80 y) with extreme obesity (BMI: ≥60 kg/m2) will be recruited from Baton Rouge, Louisiana. Exclusion criteria include major organ failure, uncontrolled endocrine disease, severe psychiatric illness, pregnancy, and inability to comply with study procedures. The total duration of participation for each individual is estimated at approximately 10 days. If qualified, participants (BMI≥60 kg/m2; n=10) will complete one outpatient visit and one inpatient visit with 36hr metabolic chamber testing.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Подробное описание

For visit 1, Subjects will arrive at the outpatient clinic following an overnight fast (nothing to eat or drink, except water, for 10 hours) and the following tests will be performed: anthropometry, blood pressure, pulse rate, temperature, pregnancy test for women, collection of fasting and timed urine samples, fasting and timed blood draws, isotope dilution for sodium bromide, dual-energy X-ray absorptiometry, bioelectrical impedance analysis, ultrasound, accelerometer distribution, and completion of multiple questionnaires. Then, participants will wear the accelerometer and complete an ASA24 questionnaire from Visit 1 to Visit 2-D1, in which participants will return for the first metabolic chamber stay. For D3-Creatine assessment, participants will be instructed to collect an additional urine sample within 5-6 days of Visit 1 that will be dropped off when they arrive for their V2-D1 visit at Pennington Biomedical.

For Visit 2-D1, seven days after being dosed with DLW, subjects will arrive at the inpatient clinic following an overnight fast (nothing to eat or drink, except water, for at least 10 hours). The purpose of this visit is to collect urine samples for D3, DLW, remove the accelerometer, and complete the first overnight metabolic chamber visit, employing a high-fat test meal to assess metabolic flexibility. During this visit, the following tests will be performed: anthropometry, blood pressure, pulse rate, temperature, fasting urine sample, fasting blood draw, accelerometer removal, standardized breakfast and lunch, 13-h overnight stay in the metabolic chamber with a high-fat dinner, urine collection throughout the chamber stay, and VAS before and after lunch and dinner.

Lastly, for Visit 2-D2, upon completing the first overnight inpatient stay in the metabolic chamber (previous 13 hours), participants will exit the chamber at 0700 for one hour to allow for re-calibration of the chambers. Participants will be fasted since their high-fat dinner meal the previous night (approximately 11.5 hours) and will have their metabolic weight taken along with a fasting blood draw. They will then re-enter the metabolic chamber at 0800 and begin a 23-h chamber stay consisting of controlled meals throughout the stay. The purpose of this visit is to collect 23-h chamber data pertaining to various metrics of energy expenditure (e.g., BMR, RMR, TEF, SMR, etc.) and substrate oxidation (i.e., respiratory quotient). During this visit, the following tests will be performed: anthropometry, blood pressure, pulse rate, temperature, fasting blood draw, 23-h stay in the metabolic chamber with controlled meals, urine collection throughout the chamber stay, and VAS before and after lunch and dinner.

After completing of the second overnight chamber stay (Visit 2-D2), participants will exit the metabolic chamber and have their metabolic weight taken.

Тип исследования

Наблюдательный

Регистрация (Оцененный)

10

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Eric Ravussin, PhD
  • Номер телефона: 2257633186
  • Электронная почта: Eric.Ravussin@pbrc.edu

Учебное резервное копирование контактов

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Да

Метод выборки

Невероятностная выборка

Исследуемая популяция

The population for this study is individuals aged 18 to 80 years old who have a BMI greater than or equal to 60 kg/m2 who are willing to consume pre-prepared meals and are willing to have biospecimens and images stored for future use. The reason for seeking to evaluate this specific population is because individuals with extreme obesity possess high surgical and comorbidity risks, but there is a very small amount of research conducted in these individuals.

Описание

Inclusion Criteria:

  • Healthy male or female
  • Between 18 - 80 years of age
  • BMI ≥60 kg/m2
  • Willing to consume pre-prepared meals
  • Willing to comply with the study procedures.
  • Willing to have biospecimens and images stored for future use.

Exclusion Criteria:

  • Diabetic individuals with complications such as:

    • Diabetic eye disease requiring laser treatment
    • Diabetic nerve disease associated with foot ulcers or amputations
    • Diabetic vascular disease associated with gangrene or amputation
    • Diabetic kidney disease accompanied by a creatinine greater than 2.0 mg/dL
    • Individuals with prior gastrointestinal surgery except appendectomy or cholecystectomy
  • Individuals with untreated thyroid disease
  • Individuals with untreated or poorly controlled binge eating disorder, bulimia, substance abuse or dependence, mania, and psychosis.
  • Women who are pregnant, trying to become pregnant, or currently breastfeeding.
  • Individuals with major organ system failure like cirrhosis, hepatic insufficiency, portal hypertension, severe renal insufficiency or on dialysis, severe arterial insufficiency, dementia or the inability to give an informed consent.
  • Being unwilling to comply with the study procedures.
  • Not willing to have biospecimens and/or images stored for future research use.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Когорты и вмешательства

Группа / когорта
Вмешательство/лечение
Metabolic Flexibility
Ten Males and females (18-80 y) with extreme obesity (BMI: ≥60 kg/m2) will complete one outpatient visit and one inpatient visit with 36 hours of metabolic chamber testing evaluate energy metabolism (expenditure and fat oxidation), metabolic flexibility (response to a high-fat test meal) using gold-standard assessments of energy metabolism, metabolic flexibility, and body composition.
Другой: High-fat test meal
At Visit 2-D1, subjects will enter the chamber at approximately 17:30 and exit the following morning at 07:00. Energy expenditure, respiratory exchange ratio (RER), and 12-h oxidation of CHO, fat, and protein will be calculated per standard PBRC protocols. While in the chamber, participants will collect all their urine for measurement of urinary nitrogen. Subjects will be served one high-fat meal while they are in the chamber (40% of the daily energy requirements).
Другие имена:
  • metabolic flexibility

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
24-hour Energy Expenditure
Временное ограничение: Day 9
24-hour energy expenditure will be assessed from participants spending 23 hours in a metabolic chamber.
Day 9
24-hour Fat Oxidation
Временное ограничение: Day 9
This will be collected from the 23-hour chamber stay during Visit 2, Day 2. Specifically, this represents the total grams of fat oxidized over the 23-hour stay, calculated from indirect calorimetry stoichiometry.
Day 9
Basal Energy Expenditure
Временное ограничение: Day 9
This represents the amount of energy expended under strict basal conditions: post-absorptive (typically 10-12h fasted), thermoneutral, fully awake but supine and motionless, no recent physical activity. This will be collected from the 23-hour metabolic chamber stay.
Day 9
Resting Energy Expenditure
Временное ограничение: Day 9
This is the energy expended at rest but under less stringent conditions than basal: seated or supine, awake, post-absorptive but with less rigor about prior activity, temperature, and emotional state. This will be collected from the 23-hour metabolic chamber stay.
Day 9
Sleeping Metabolic Rate
Временное ограничение: Day 9
This is the energy expenditure during sleep, typically computed from the lowest stable ~3-hour window between roughly 02:00 and 05:00 when arousal and movement are minimal. Per our Standard Operating Procedures, this will be computed between 01:00 and 05:00.
Day 9
Thermic Effect of Food
Временное ограничение: Day 9
This represents the postprandial rise in energy expenditure above the pre-meal baseline, integrated over the period until energy expenditure returns to baseline (typically 4-6 hours for a mixed meal). This reflects the energy cost of digestion, absorption, and substrate processing, plus a sympathetic activation component.
Day 9
Spontaneous Physical Activity
Временное ограничение: Day 9
This is the energy expended on non-volitional movement: fidgeting, postural adjustments, small spontaneous movements during otherwise sedentary periods in the chamber. It is commonly measured by radar/Doppler motion sensors and quantified either as a fraction of chamber time active (% activity) or as the energy cost of activity above sleeping metabolic rate.
Day 9
Free-living Total Daily Energy Expenditure
Временное ограничение: Day 1 to Day 8
This is the gold-standard free-living EE measurement: participants drink a dose of ²H₂¹⁸O, and the differential elimination rates of the two isotopes over ~7-14 days yield CO₂ production and therefore EE under habitual living conditions. It captures everything the chamber misses: occupational and recreational activity, environmental temperature variation, real meal patterns.
Day 1 to Day 8

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Time to Food Quotient
Временное ограничение: Day 8
This is the amount of minutes from meal ingestion until RER first reaches (or crosses) the meal's FQ. This represents the speed of the switch of fuel oxidation rather than its endpoint. A flexible system gets there quickly; an inflexible one takes hours or never arrives.
Day 8
Respiratory Exchange Ratio: Food Quotient Ratio
Временное ограничение: Day 8
This is the measured respiratory exchange ratio divided by the meal's food quotient (the theoretical RER if the meal were fully oxidized as ingested). A ratio of 1.0 means whole-body substrate oxidation has fully matched the macronutrient composition of what was just eaten; <1.0 means oxidation is lagging behind intake (fat-dominant fuel selection persisting after a mixed or high-carb meal); >1.0 means net lipogenesis or carryover carb oxidation. The FQ of the high-fat test meal will be used.
Day 8
ΔRespiratory Exchange Ratio Nadir
Временное ограничение: Day 8
This represents the drop from a reference RER (typically pre-meal fasting baseline, sometimes overnight minimum) to the lowest RER value observed. In a high-fat meal challenge this captures the magnitude of the fat-oxidation excursion: how far down the RER pushes when the meal is fat-dominant.
Day 8
Post-meal Respiratory Exchange Ratio Slope
Временное ограничение: Day 8
This represents the rate of RER change in the early postprandial window, usually fit as a linear slope over the first 30-90 minutes after ingestion. A steep slope would mean a rapid switch (metabolically flexible) and a shallow slope would indicate impaired metabolic flexibility.
Day 8
Time to Respiratory Exchange Ratio Nadir
Временное ограничение: Day 8
This represents the amount of minutes from high-fat meal meal ingestion until RER reaches its lowest value. Pairing this will the change in RER nadir helps describe the fat oxidation excursion. That is, nadir magnitude expresses how much fat oxidation increased, whereas time-to-nadir exhibits how long it took to get there.
Day 8

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Skeletal Muscle Mass
Временное ограничение: Day 1 to Day 5
Skeletal muscle mass will be measured using D3-creatine dilution. Participants will be administered a 60 mg capsule with D3-creatine during Visit 1. Spot urine specimens will be collected between 120 hours (5 days) and 144 hours (6 days) after administration of the D3-creatine dose.
Day 1 to Day 5
Fat-free Mass
Временное ограничение: Day 1
Fat-free mass will be quantified by dual-energy X-ray absorptiometry and two bioelectrical impedance analysis devices (InBody S10 and ImpediMed SFB7) during visit 1.
Day 1
Fat Mass
Временное ограничение: Day 1
Fat mass will be estimated by dual-energy X-ray absorptiometry and two bioelectrical impedance analysis devices (InBody S10 and ImpediMed SFB7) during visit 1.
Day 1
Body Fat Percentage
Временное ограничение: Day 1
Body fat percentage will be estimated by dual-energy X-ray absorptiometry and two bioelectrical impedance analysis devices (InBody S10 and ImpediMed SFB7) during visit 1.
Day 1
Extracellular Water
Временное ограничение: Day 1
At Visit 1, a blood sample of 3 ml will be collected before ingesting an appropriate amount of sodium bromide based on body weight diluted in deionized water. A blood sample of 3 ml will be collected 4 hours after ingestion. During the 4-hour period participants must refrain from eating anything, but they can drink water if needed.
Day 1
Total Body Water
Временное ограничение: Day 1
Total body water will be determined via two bioelectrical impedance devices (InBody S10 and ImpediMed SFB7) and deuterium dilution.
Day 1

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Pennington Biomedical Research Center

Следователи

  • Главный следователь: Christian Rodriguez, PhD, Pennington Biomedical Research Center

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 июля 2026 г.

Первичное завершение (Оцененный)

1 июля 2026 г.

Завершение исследования (Оцененный)

1 августа 2026 г.

Даты регистрации исследования

Первый отправленный

13 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

26 мая 2026 г.

Первый опубликованный (Действительный)

29 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

29 мая 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

26 мая 2026 г.

Последняя проверка

1 мая 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • PBRC 2026-011

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕ РЕШЕНО

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования ИМТ>40

Искать похожие исследования

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

CROs by country

CROs in France

Заболевания

Редкие заболевания

Медикаментозные вмешательства

Пищевые добавки

Спонсор / Соавторы

Места

Подписаться