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Study of the Effects of Overfeeding on Glucocorticoids in Lean and Obese Subjects

The Acute Response of Glucocorticoids Upon Food Intake

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04482738
Acronym
Gluco-Food
Enrollment
36
Registered
2020-07-22
Start date
2020-05-14
Completion date
2021-02-20
Last updated
2022-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Keywords

obesity, overweight, cortisol, overfeeding, glucocorticoids

Brief summary

Investigators suggest that in lean subjects cortisol increases in response to overfeeding and that this increase is blunted in obese subjects. A group of 18 male healthy lean subjects and another group of 18 male healthy obese subjects will undergo a high-calorie meal test. Prior to the meal intake, an indirect calorimetry, bioelectrical impedance, heart rate variability, a fasting blood sample and a perceived stress questionnaire will be assessed. After intake of the study meal, blood tests will be performed in order to measure the secretion of cortisol, glucose and lipid metabolism and inflammatory markers. Indirect calorimetry will be assessed again 60 and 180 minutes after the meal intake.

Detailed description

Obesity is one of the most serious health problems in the 21st century. High energy food and a sedentary lifestyle are driving the current obesity pandemic. These factors activate the hypothalamic-pituitary-adrenal (HPA) axis, the key regulatory pathway of energy homeostasis. Activation of the HPA-axis leads to secretion of glucocorticoids from the adrenal glands, which control energy homeostasis by mobilizing and redistributing energy substrates. Animal models of obesity have shown that glucocorticoids play a key role in the development of the metabolic syndrome. However, studies in humans yielded conflicting results. These studies have a major limitation in common. They do not consider glucocorticoid rhythmicity but rather investigate a snapshot of glucocorticoid secretion. Rhythmicity, however, is crucial because already minor glucocorticoid phase disturbances cause disease and could contribute to obesity. Interestingly, excessive food intake may increase cortisol levels in healthy subjects . The consequence of this food-induced cortisol peak is not understood, but it may be key to restoring energy homeostasis after a meal. Whether the food-induced cortisol peak in obese subjects is disturbed is not known With this study, investigators aim to better understand the role played by glucocorticoids in the origin of overweight and obesity. Researchers will investigate, in lean and obese subjects, whether the pulsatile release of cortisol increases after intake of a high-calorie meal. 36 subjects will take part in the study: a group of 18 male lean subjects and a second group of 18 male obese patients.

Interventions

OTHERHigh-calorie meal

Intake of a high-calorie meal (2500-3000 calories) within 15 minutes.

Sponsors

Novartis
CollaboratorINDUSTRY
Eleonora Seelig
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Body mass index (BMI) \>18,5 and \<25 kg/m2 * BMI \>30 kg/m2

Exclusion criteria

* Any clinically significant concomitant diseases in lean subjects * Any clinically significant concomitant diseases in obese subjects apart from features of the metabolic syndrome (dyslipidemia, arterial hypertension and insulin resistance) * Lactose intolerance * Severe food allergy * Regular alcohol consumption (\>30 g/d) * Regular fitness training (\>4 hours/week) * Previous enrolment in a clinical trial within the last 3 months * Inability or contradictions to undergo the investigated intervention * Inability to follow the procedures of the study

Design outcomes

Primary

MeasureTime frameDescription
Change in pulsatile secretion of cortisol in response to a high-calorie meal (nmol/l)195 minutesBlood test

Secondary

MeasureTime frameDescription
Interleukin-8 (IL-8) (pg/ml)195 minutesBlood test
Interleukin-1 receptor Antagonist (IL-1Ra) (pg/ml)195 minutesBlood test
Heart rate (bpm)5 minutesHeart rate variability analysis
Blood pressure: diastolic and systolic blood pressure (mmHg)1 minuteStandard blood pressure monitor
Weight: kilogram body weight (kg)1 minuteStandard scale
Energy expenditure: basal metabolic rate200 minutesIndirect calorimetry
Substrate utilisation: respiratory quotient200 minutesIndirect calorimetry
Fat and lean mass (kg)20 minutesBody impedance analysis
Total body water (l)20 minutesBody impedance analysis
Appetite: visual analogue scale rating3 hoursVisual analogue scale
Stress: perceived stress Levels (0-56)5 minutesPerceived stress questionnaire
Low density lipoprotein (LDL)-cholesterol (mmol/l)195 minutesBlood test
High density lipoprotein (HDL)-cholesterol (mmol/l)195 minutesBlood test
Triglycerides (mmol/l)195 minutesBlood test
Growth differentiation factor 15 (GDF15) (ng/l)195 minutesBlood test
High-sensitive c-reactive Protein (hsCRP) (mg/l)195 minutesBlood test
Interleukin-6 (IL-6) (pg/ml)195 minutesBlood test
Thyroid hormones (nmol/l)195 minutesBlood test
Growth Hormone (mIU/l)195 minutesBlood test
Catecholamines (pg/ml)195 minutesBlood test
Adrenocorticotropic Hormone (ACTH) (pg/ml)195 minutesBlood test
Glucagon-like-peptide-1 (GLP-1) (pg/ml)195 minutesBlood test
Gastric inhibitory polypeptide (GIP) (pg/ml)195 minutesBlood test
Peptide YY (PYY) (pg/ml)195 minutesBlood test
Glucose (mmol/l)195 minutesBlood test
Insulin (mIU/l)195 minutesBlood test
C-Peptide (pmol/l)195 minutesBlood test
Total cholesterol (mmol/l)195 minutesBlood test

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026