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

Overweight and Obesity Clinical Trial

— Gluco-Food  

Official title:

The Acute Response of Glucocorticoids Upon Food Intake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04482738
• Other study ID #: 202000384
• Status: Completed
• Start date: May 14, 2020
• Est. completion date: February 20, 2021

Study information

• Verified date: March 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 20, 2021
• Est. primary completion date: February 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel	Basel-Stadt

Sponsors (2)

Lead Sponsor	Collaborator
Eleonora Seelig	Novartis

Country where clinical trial is conducted

Switzerland, 

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pulsatile secretion of cortisol in response to a high-calorie meal (nmol/l)	Blood test	195 minutes
Secondary	Thyroid hormones (nmol/l)	Blood test	195 minutes
Secondary	Growth Hormone (mIU/l)	Blood test	195 minutes
Secondary	Catecholamines (pg/ml)	Blood test	195 minutes
Secondary	Adrenocorticotropic Hormone (ACTH) (pg/ml)	Blood test	195 minutes
Secondary	Glucagon-like-peptide-1 (GLP-1) (pg/ml)	Blood test	195 minutes
Secondary	Gastric inhibitory polypeptide (GIP) (pg/ml)	Blood test	195 minutes
Secondary	Peptide YY (PYY) (pg/ml)	Blood test	195 minutes
Secondary	Glucose (mmol/l)	Blood test	195 minutes
Secondary	Insulin (mIU/l)	Blood test	195 minutes
Secondary	C-Peptide (pmol/l)	Blood test	195 minutes
Secondary	Total cholesterol (mmol/l)	Blood test	195 minutes
Secondary	Low density lipoprotein (LDL)-cholesterol (mmol/l)	Blood test	195 minutes
Secondary	High density lipoprotein (HDL)-cholesterol (mmol/l)	Blood test	195 minutes
Secondary	Triglycerides (mmol/l)	Blood test	195 minutes
Secondary	Growth differentiation factor 15 (GDF15) (ng/l)	Blood test	195 minutes
Secondary	High-sensitive c-reactive Protein (hsCRP) (mg/l)	Blood test	195 minutes
Secondary	Interleukin-6 (IL-6) (pg/ml)	Blood test	195 minutes
Secondary	Interleukin-8 (IL-8) (pg/ml)	Blood test	195 minutes
Secondary	Interleukin-1 receptor Antagonist (IL-1Ra) (pg/ml)	Blood test	195 minutes
Secondary	Heart rate (bpm)	Heart rate variability analysis	5 minutes
Secondary	Blood pressure: diastolic and systolic blood pressure (mmHg)	Standard blood pressure monitor	1 minute
Secondary	Weight: kilogram body weight (kg)	Standard scale	1 minute
Secondary	Energy expenditure: basal metabolic rate	Indirect calorimetry	200 minutes
Secondary	Substrate utilisation: respiratory quotient	Indirect calorimetry	200 minutes
Secondary	Fat and lean mass (kg)	Body impedance analysis	20 minutes
Secondary	Total body water (l)	Body impedance analysis	20 minutes
Secondary	Appetite: visual analogue scale rating	Visual analogue scale	3 hours
Secondary	Stress: perceived stress Levels (0-56)	Perceived stress questionnaire	5 minutes