Study of the Effects of Overfeeding on Glucocorticoids in Lean and Obese Subjects
- Conditions
- Overweight and Obesity
- Interventions
- Other: High-calorie meal
- Registration Number
- NCT04482738
- Lead Sponsor
- Eleonora Seelig
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
- Body mass index (BMI) >18,5 and <25 kg/m2
- BMI >30 kg/m2
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Obese subjects High-calorie meal 24 hours before the study visit, participants will be asked to refrain from alcohol and strenuous exercise. Patients will be asked to remain fasted 10 hours before the study visit takes place. On the day of the study visit, patients will be admitted to the hospital and, after intake of the study meal, blood samples will be taken. Lean subjects High-calorie meal 24 hours before the study visit, participants will be asked to refrain from alcohol and strenuous exercise. Patients will be asked to remain fasted 10 hours before the study visit takes place. On the day of the study visit, patients will be admitted to the hospital and, after intake of the study meal, blood samples will be taken.
- Primary Outcome Measures
Name Time Method Change in pulsatile secretion of cortisol in response to a high-calorie meal (nmol/l) 195 minutes Blood test
- Secondary Outcome Measures
Name Time Method Low density lipoprotein (LDL)-cholesterol (mmol/l) 195 minutes Blood test
Growth differentiation factor 15 (GDF15) (ng/l) 195 minutes Blood test
High-sensitive c-reactive Protein (hsCRP) (mg/l) 195 minutes Blood test
Substrate utilisation: respiratory quotient 200 minutes Indirect calorimetry
Fat and lean mass (kg) 20 minutes Body impedance analysis
Thyroid hormones (nmol/l) 195 minutes Blood test
Growth Hormone (mIU/l) 195 minutes Blood test
Catecholamines (pg/ml) 195 minutes Blood test
Adrenocorticotropic Hormone (ACTH) (pg/ml) 195 minutes Blood test
Glucagon-like-peptide-1 (GLP-1) (pg/ml) 195 minutes Blood test
High density lipoprotein (HDL)-cholesterol (mmol/l) 195 minutes Blood test
Gastric inhibitory polypeptide (GIP) (pg/ml) 195 minutes Blood test
Peptide YY (PYY) (pg/ml) 195 minutes Blood test
Glucose (mmol/l) 195 minutes Blood test
Insulin (mIU/l) 195 minutes Blood test
C-Peptide (pmol/l) 195 minutes Blood test
Interleukin-8 (IL-8) (pg/ml) 195 minutes Blood test
Total cholesterol (mmol/l) 195 minutes Blood test
Triglycerides (mmol/l) 195 minutes Blood test
Interleukin-6 (IL-6) (pg/ml) 195 minutes Blood test
Blood pressure: diastolic and systolic blood pressure (mmHg) 1 minute Standard blood pressure monitor
Energy expenditure: basal metabolic rate 200 minutes Indirect calorimetry
Interleukin-1 receptor Antagonist (IL-1Ra) (pg/ml) 195 minutes Blood test
Heart rate (bpm) 5 minutes Heart rate variability analysis
Weight: kilogram body weight (kg) 1 minute Standard scale
Total body water (l) 20 minutes Body impedance analysis
Appetite: visual analogue scale rating 3 hours Visual analogue scale
Stress: perceived stress Levels (0-56) 5 minutes Perceived stress questionnaire
Trial Locations
- Locations (1)
University Hospital Basel
🇨🇭Basel, Basel-Stadt, Switzerland