- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07690176
How the Body Processes Sugar After Eating, in People With Different Body Weights
The Metabolic Effects of a Hyperglycaemic Meal in Lean and Obese Individuals Using a [14C]-Glucose Microtracer Approach
Обзор исследования
Статус
Условия
Подробное описание
Obesity is associated with substantial metabolic dysregulation, including impaired glucose handling, increased oxidative stress, and altered nutrient partitioning. A metabolic pathway of particular interest in this context is the polyol pathway, in which glucose is converted to sorbitol by aldose reductase and subsequently to fructose. Preclinical studies suggest that flux through this pathway increases when intracellular glucose concentrations rise, such as during hyperglycaemia or insulin resistance. Greater activity of this pathway has been linked to the formation of advanced glycation end products, oxidative stress, and stimulation of de novo lipogenesis. These mechanisms have been proposed as contributors to metabolic complications commonly observed in individuals with obesity. Despite these findings from animal and in vitro studies, polyol pathway activity and its regulation by dietary glycaemic load have not been systematically quantified in humans. This clinical trial addresses this gap by applying a highly sensitive [14C]-glucose microtracer approach to measure the metabolic fate of glucose following ingestion of meals with differing glycaemic properties in lean individuals and individuals with obesity.
The study makes use of uniformly labelled [14C]-glucose, which allows tracing of glucose-derived carbon into metabolic intermediates, expired CO₂, urine, faeces, and lipids using Accelerator Mass Spectrometry. This technology enables quantification of metabolic products with extremely small isotope doses, resulting in radiation exposure far below natural background levels. Through this approach, the study can directly assess the extent to which ingested glucose is oxidized, converted into polyol pathway intermediates, incorporated into lipids, or excreted. The microtracer method provides a level of mechanistic resolution that cannot be achieved with stable isotopes or traditional metabolic tests.
The study design includes a single 72-hour metabolic test period during which participants consume either a high- or low-glycaemic breakfast depending on group allocation. The subsequent ingestion of [14C]-glucose allows tracking of postprandial metabolic routing under these two dietary conditions. Lean participants are randomized to either glycaemic condition, whereas individuals with obesity receive the high-glycaemic meal to address the study's main objective of comparing pathway activity between lean and obese phenotypes under hyperglycaemic challenge. Although the protocol includes multiple laboratory measurements, the aim of this Detailed Description is not to reproduce the procedure schedule, but to summarize the scientific characteristics of the design. In general terms, the study integrates whole-body, biochemical, and tissue-level metabolic assessments to characterize glucose metabolism in vivo.
Whole-body energy expenditure and substrate oxidation are measured repeatedly through indirect calorimetry to determine the proportion of glucose that is oxidized versus stored or redirected into other metabolic pathways. Breath samples are collected to quantify 14CO₂ production, which provides a sensitive measure of glucose oxidation and contributes to mass balance calculations. Serial blood sampling enables the measurement of plasma glucose, insulin, and the appearance of 14C-labelled metabolites, providing insight into the dynamics of glucose disposal and conversion to sorbitol, fructose, and downstream metabolites.
A distinctive feature of this study is the assessment of forearm arteriovenous metabolite balance, obtained from arterialized and deep-venous blood sampling combined with Doppler ultrasound measurement of forearm blood flow. This technique allows calculation of tissue-specific uptake and release of glucose and glucose-derived metabolites across skeletal muscle, a major site of postprandial glucose disposal. These measurements offer a physiologically meaningful index of muscle insulin sensitivity and provide additional perspective on how glycaemic load and obesity influence metabolic flux at the tissue level.
Collection of urine and faeces for 72 hours enables full recovery of the administered tracer, allowing detailed mass balance calculations. This information reveals how much of the ingested glucose is oxidized, excreted, or directed into biosynthetic pathways. By integrating data from breath, blood, urine, and faeces, the study can comprehensively map the metabolic fate of glucose and determine how this differs across physiological states.
The primary scientific questions addressed by this study are whether polyol pathway activity increases under hyperglycaemic conditions in humans and whether individuals with obesity demonstrate greater pathway activation than lean individuals. The study further explores the relationship between polyol pathway activation and de novo lipogenesis and evaluates whether the glycaemic load of a meal modulates these pathways. By combining microtracer-based flux analysis with whole-body and tissue-specific measurements, the study aims to provide mechanistic insight into early metabolic disturbances associated with obesity.
Overall, this trial will generate foundational human data on endogenous fructose production and glucose routing in response to dietary glycaemic load. These findings may contribute to improved understanding of how carbohydrate metabolism becomes dysregulated in obesity and may support the development of nutritional or therapeutic strategies targeting glucose-handling pathways. The study also demonstrates the potential of Accelerator Mass Spectrometry as a powerful tool for investigating nutrient metabolism in vivo with minimal participant burden and extremely low radiation exposure.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Marlou Dirks, PhD
- Номер телефона: +31 317-484 136
- Электронная почта: Marlou.Dirks@wur.nl
Учебное резервное копирование контактов
- Имя: Ayesha Heinis, PhD
- Номер телефона: +31 6-21578392
- Электронная почта: ayesha.heinis@wur.nl
Места учебы
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Wageningen, Нидерланды, 6708 WD
- Рекрутинг
- Wageningen University and Research
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Контакт:
- Ayesha Heinis, PhD
- Номер телефона: 0621578392
- Электронная почта: ayesha.heinis@wur.nl
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Контакт:
- Marlou Dirks, PhD
- Номер телефона: 0031317-484 136
- Электронная почта: marlou.dirks@wur.nl
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Healthy males and females using contraception during and for 3 months after the study.
- Aged from 18-65 years at the time of signing informed consent
- 18.5 < BMI < 25 kg·m2 or 30< BMI <35 kg·m2
- Must be willing and able to communicate and participate in the whole study, including consumption of 14C-glucose and meals offered during study conduct
- Must have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)
- Must usually eat 3 meals per day (i.e. breakfast, lunch and dinner)
Exclusion Criteria:
- Diabetes (Type 1, Type 2, or genetic form of diabetes)
- Any diagnosed cardiovascular (heart) disease or high blood pressure (≥140 mmHg systolic and/or ≥90 mmHg diastolic)
- HbA1c higher than 53 mmol/mol
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastro-intestinal disease, immunodeficiency, endocrine, neurological, or psychiatric disorders
- Any diagnosed respiratory disease, such as COPD or asthma
- Any previous motor disorders or disorders in muscle and/or lipid metabolism
- Known severe kidney problems
- Presence of an ulcer in the stomach or gut and/or strong history of indigestion
- Recent or chronic history of diarrhoea
- Known anaemia
- A personal or family history of thrombosis (clots), epilepsy, seizures, or schizophrenia.
- Regular use of dietary supplements (>3 times per week)
- Chronic use of any prescribed or over the counter pharmaceuticals (excluding oral contraceptives and contraceptive devices)
- History of any drug or alcohol abuse in the past two years
- A confirmed positive alcohol breath test at screening or admission
- Drug use
- Claustrophobia
- Subjects who are on a weight loss diet or following a high calorific/high protein diet to gain weight
- Subjects with functional constipation
- Any known food allergies or intolerances to the 14 major food allergens (celery, cereals containing gluten, crustaceans, eggs, fish, lupin, milk, molluscs, mustard, tree nuts, peanuts, sesame seeds, soybeans, sulphur dioxide and sulphites) or history of a malabsorption syndrome including coeliac disease
- Subjects who have regular gastrointestinal complaints including abdominal pain, stomach upsets and borborygmi or known or suspected irritable bowel syndrome
- Currently taking part in another scientific research
- Having received a product with 14C in the past 12 months
- Pregnant or breastfeeding
- Smoking or having used nicotine-containing products in the 6 months prior to the study.
- Subjects who have taken antibiotics within the 60 days prior to the adaptation period.
- Currently involved in a structured progressive resistance training programme (>3 times per week)
- Sedentary lifestyle as assessed using the International Physical Activity Questionnaire [IPAQ].
- Unable to give consent
- Employed or undertaking a thesis or internship at the department of Human and Animal Physiology
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: A - Lean individuals (Low-glycemic breakfast)
Lean participants randomized to consume a low-glycemic breakfast prior to administration of an oral [¹⁴C]-glucose microtracer to assess postprandial glucose metabolism.
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Participants receive a single oral microtracer dose of [14C] glucose (≤10 kBq / 270 nCi) mixed with 1 g unlabeled glucose, administered immediately after a low glycemic breakfast.
The dose is prepared fresh on the morning of administration and consumed as a liquid drink.
This approach enables tracing of glucose metabolism using Accelerator Mass Spectrometry (AMS) at extremely low radiation exposure (~0.006 mSv).
The intervention is combined with indirect calorimetry, serial blood sampling (including arterialized and deep-venous lines), expired air collection for 14CO₂ recovery, and pooled urine/feces collection over 72 hours to quantify metabolic fate and pathway activity.
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Экспериментальный: B - Lean individuals (High-glycemic breakfast)
Lean participants randomized to consume a high-glycemic breakfast prior to administration of an oral [¹⁴C]-glucose microtracer to assess postprandial glucose metabolism.
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Participants receive a single oral microtracer dose of [14C] glucose (≤10 kBq / 270 nCi) mixed with 1 g unlabeled glucose, administered immediately after a high glycemic breakfast.
The dose is prepared fresh on the morning of administration and consumed as a liquid drink.
This approach enables tracing of glucose metabolism using Accelerator Mass Spectrometry (AMS) at extremely low radiation exposure (~0.006 mSv).
The intervention is combined with indirect calorimetry, serial blood sampling (including arterialized and deep-venous lines), expired air collection for 14CO₂ recovery, and pooled urine/feces collection over 72 hours to quantify metabolic fate and pathway activity.
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Экспериментальный: C - Individuals with obesity (High-glycemic breakfast)
Participants with obesity consume a high-glycemic breakfast prior to administration of an oral [¹⁴C]-glucose microtracer to assess postprandial glucose metabolism.
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Participants receive a single oral microtracer dose of [14C] glucose (≤10 kBq / 270 nCi) mixed with 1 g unlabeled glucose, administered immediately after a high glycemic breakfast.
The dose is prepared fresh on the morning of administration and consumed as a liquid drink.
This approach enables tracing of glucose metabolism using Accelerator Mass Spectrometry (AMS) at extremely low radiation exposure (~0.006 mSv).
The intervention is combined with indirect calorimetry, serial blood sampling (including arterialized and deep-venous lines), expired air collection for 14CO₂ recovery, and pooled urine/feces collection over 72 hours to quantify metabolic fate and pathway activity.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Total mass balance (cumulative recovery of 14C)
Временное ограничение: Baseline to 72 hours post dose
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Cumulative recovery of total radioactivity across all excreta (urine, faeces, and expired CO₂) expressed as percentage of the administered dose.
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Baseline to 72 hours post dose
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Polyol pathway activity (fructose-to-glucose ratio)
Временное ограничение: Baseline to 72 hours post 14C ingestion
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Ratio of 14C-fructose to 14C-glucose concentrations
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Baseline to 72 hours post 14C ingestion
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Polyol pathway activity (sorbitol-to-glucose ratio)
Временное ограничение: Baseline to 72 hours post 14C ingestion
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Ratio of 14C-sorbitol to 14C-glucose concentrations
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Baseline to 72 hours post 14C ingestion
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Polyol pathway activity (AUC-based ratio)
Временное ограничение: Baseline to 72 hours post 14C ingestion
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Ratio of area under the curve (AUC) for 14C-fructose to AUC for 14C-glucose
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Baseline to 72 hours post 14C ingestion
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De novo lipogenesis from glucose
Временное ограничение: Baseline to 72 hours
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Incorporation of 14C label into plasma lipids as a measure of fatty acid synthesis from glucose
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Baseline to 72 hours
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Caloric value of glucose
Временное ограничение: Baseline to 72 hours
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Recovery of 14C label in expired CO2 and excreta, expressed as a measure of energy yield of ingested glucose
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Baseline to 72 hours
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Forearm arteriovenous balance of 14C-glucose and metabolites
Временное ограничение: 0-240 minutes post dose
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Arteriovenous concentration differences of 14C-glucose and metabolites across the forearm, combined with blood flow measurements
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0-240 minutes post dose
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14C-labelled metabolites in carbohydrate metabolism pathways
Временное ограничение: Baseline to 72 hours post 14C ingestion
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Concentrations and 14C-enrichment of glucose, fructose, and related metabolites in plasma and erythrocytes.
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Baseline to 72 hours post 14C ingestion
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Carbohydrate oxidation
Временное ограничение: Baseline to 72 hours
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Carbohydrate oxidation rate measured using indirect calorimetry and calculated according to standard equations under fasted and postprandial conditions following ingestion of a high- or low-glycaemic meal.
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Baseline to 72 hours
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Lipid oxidation
Временное ограничение: Baseline to 72 hours
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Lipid oxidation rate measured using indirect calorimetry and calculated according to standard equations under fasted and postprandial conditions following ingestion of a high- or low-glycaemic meal.
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Baseline to 72 hours
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Energy expenditure
Временное ограничение: Baseline to 72 hours
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Total energy expenditure measured using indirect calorimetry and calculated according to standard equations under fasted and postprandial conditions following ingestion of a high- or low-glycaemic meal.
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Baseline to 72 hours
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Polyol Pathway Activity Markers
Временное ограничение: Baseline and up to 8 hours after 14C-glucose ingestion
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Plasma and erythrocyte sorbitol concentrations
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Baseline and up to 8 hours after 14C-glucose ingestion
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Plasma glucose
Временное ограничение: Baseline and up to 8 hours after 14C-glucose ingestion
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Plasma glucose concentration
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Baseline and up to 8 hours after 14C-glucose ingestion
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Insulin
Временное ограничение: Baseline and up to 8 hours after 14C-glucose ingestion
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Serum insulin concentration
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Baseline and up to 8 hours after 14C-glucose ingestion
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Exploratory Metabolic Phenotyping
Временное ограничение: Baseline and up to 8 hours after 14C-glucose ingestion
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Metabolomic, proteomic, and/or transcriptomic profiles in plasma and erythrocytes
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Baseline and up to 8 hours after 14C-glucose ingestion
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Body Weight
Временное ограничение: Baseline (pre-intervention)
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Body weight measured in kilograms
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Baseline (pre-intervention)
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Height
Временное ограничение: Baseline (pre-intervention)
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Height measured in meters
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Baseline (pre-intervention)
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Body mass index (BMI)
Временное ограничение: Baseline (pre-intervention)
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Body mass index calculated as weight in kilograms divided by height in meters squared (kg/m²)
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Baseline (pre-intervention)
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Blood pressure
Временное ограничение: Baseline (pre-intervention)
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Systolic and diastolic blood pressure measured in mmHg
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Baseline (pre-intervention)
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Glycated haemoglobin (HbA1c)
Временное ограничение: Baseline
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HbA1c concentration in blood
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Baseline
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Marlou Dirks, PhD, Wageningen University
Публикации и полезные ссылки
Общие публикации
- Kruszynska YT, Mulford MI, Yu JG, Armstrong DA, Olefsky JM. Effects of nonesterified fatty acids on glucose metabolism after glucose ingestion. Diabetes. 1997 Oct;46(10):1586-93. doi: 10.2337/diacare.46.10.1586.
- Fery F, d'Attellis NP, Balasse EO. Mechanisms of starvation diabetes: a study with double tracer and indirect calorimetry. Am J Physiol. 1990 Dec;259(6 Pt 1):E770-7. doi: 10.1152/ajpendo.1990.259.6.E770.
- Moseley L, Jentjens RL, Waring RH, Harris RM, Harding LK, Jeukendrup AE. Measurement of exogenous carbohydrate oxidation: a comparison of [U-14C]glucose and [U-13C]glucose tracers. Am J Physiol Endocrinol Metab. 2005 Aug;289(2):E206-11. doi: 10.1152/ajpendo.00423.2004. Epub 2005 Feb 22.
- Wisneski JA, Gertz EW, Neese RA, Gruenke LD, Craig JC. Dual carbon-labeled isotope experiments using D-[6-14C] glucose and L-[1,2,3-13C3] lactate: a new approach for investigating human myocardial metabolism during ischemia. J Am Coll Cardiol. 1985 May;5(5):1138-46. doi: 10.1016/s0735-1097(85)80016-4.
- Virkamaki A, Puhakainen I, Nurjhan N, Gerich JE, Yki-Jarvinen H. Measurement of lactate formation from glucose using [6-3H]- and [6-14C]glucose in humans. Am J Physiol. 1990 Sep;259(3 Pt 1):E397-404. doi: 10.1152/ajpendo.1990.259.3.E397.
- Bell PM, Firth RG, Rizza RA. Assessment of insulin action in insulin-dependent diabetes mellitus using [6(14)C]glucose, [3(3)H]glucose, and [2(3)H]glucose. Differences in the apparent pattern of insulin resistance depending on the isotope used. J Clin Invest. 1986 Dec;78(6):1479-86. doi: 10.1172/JCI112739.
- McMahon MM, Schwenk WF, Haymond MW, Rizza RA. Underestimation of glucose turnover measured with [6-3H]- and [6,6-2H]- but not [6-14C]glucose during hyperinsulinemia in humans. Diabetes. 1989 Jan;38(1):97-107. doi: 10.2337/diab.38.1.97.
- Katz H, Homan M, Butler P, Rizza R. Use of [3-3H]glucose and [6-14C]glucose to measure glucose turnover and glucose metabolism in humans. Am J Physiol. 1992 Jul;263(1 Pt 1):E17-22. doi: 10.1152/ajpendo.1992.263.1.E17.
- Ferrannini E, Bjorkman O, Reichard GA Jr, Pilo A, Olsson M, Wahren J, DeFronzo RA. The disposal of an oral glucose load in healthy subjects. A quantitative study. Diabetes. 1985 Jun;34(6):580-8. doi: 10.2337/diab.34.6.580.
- Gallen IW, Macdonald IA. Effect of two methods of hand heating on body temperature, forearm blood flow, and deep venous oxygen saturation. Am J Physiol. 1990 Nov;259(5 Pt 1):E639-43. doi: 10.1152/ajpendo.1990.259.5.E639.
- ANDRES R, ZIERLER KL, ANDERSON HM, STAINSBY WN, CADER G, GHRAYYIB AS, LILIENTHAL JL Jr. Measurement of blood flow and volume in the forearm of man; with notes on the theory of indicator-dilution and on production of turbulence, hemolysis, and vasodilatation by intra-vascular injection. J Clin Invest. 1954 Apr;33(4):482-504. doi: 10.1172/JCI102919. No abstract available.
- Dirks ML, Wall BT, Otten B, Cruz AM, Dunlop MV, Barker AR, Stephens FB. High-fat Overfeeding Does Not Exacerbate Rapid Changes in Forearm Glucose and Fatty Acid Balance During Immobilization. J Clin Endocrinol Metab. 2020 Jan 1;105(1):dgz049. doi: 10.1210/clinem/dgz049.
- Batchuluun B, Pinkosky SL, Steinberg GR. Lipogenesis inhibitors: therapeutic opportunities and challenges. Nat Rev Drug Discov. 2022 Apr;21(4):283-305. doi: 10.1038/s41573-021-00367-2. Epub 2022 Jan 14.
- Lambert JE, Ramos-Roman MA, Browning JD, Parks EJ. Increased de novo lipogenesis is a distinct characteristic of individuals with nonalcoholic fatty liver disease. Gastroenterology. 2014 Mar;146(3):726-35. doi: 10.1053/j.gastro.2013.11.049. Epub 2013 Dec 4.
- Donnelly KL, Smith CI, Schwarzenberg SJ, Jessurun J, Boldt MD, Parks EJ. Sources of fatty acids stored in liver and secreted via lipoproteins in patients with nonalcoholic fatty liver disease. J Clin Invest. 2005 May;115(5):1343-51. doi: 10.1172/JCI23621.
- Johnson RJ, Lanaspa MA, Sanchez-Lozada LG, Tolan D, Nakagawa T, Ishimoto T, Andres-Hernando A, Rodriguez-Iturbe B, Stenvinkel P. The fructose survival hypothesis for obesity. Philos Trans R Soc Lond B Biol Sci. 2023 Sep 11;378(1885):20220230. doi: 10.1098/rstb.2022.0230. Epub 2023 Jul 24.
- Tang WH, Martin KA, Hwa J. Aldose reductase, oxidative stress, and diabetic mellitus. Front Pharmacol. 2012 May 9;3:87. doi: 10.3389/fphar.2012.00087. eCollection 2012.
- Kivimaki M, Strandberg T, Pentti J, Nyberg ST, Frank P, Jokela M, Ervasti J, Suominen SB, Vahtera J, Sipila PN, Lindbohm JV, Ferrie JE. Body-mass index and risk of obesity-related complex multimorbidity: an observational multicohort study. Lancet Diabetes Endocrinol. 2022 Apr;10(4):253-263. doi: 10.1016/S2213-8587(22)00033-X. Epub 2022 Mar 4.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- NL85522.028.24
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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