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

NCT04482738 | Completed

• 1 other identifier: 202000384
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

obesity; overweight; cortisol; overfeeding; glucocorticoids

Outcome Measures

Primary Outcomes (1)

• Change in pulsatile secretion of cortisol in response to a high-calorie meal (nmol/l)

  Blood test

  195 minutes

Secondary Outcomes (28)

• Thyroid hormones (nmol/l)

  195 minutes

• Growth Hormone (mIU/l)

  195 minutes

• Catecholamines (pg/ml)

  195 minutes

• Adrenocorticotropic Hormone (ACTH) (pg/ml)

  195 minutes

• Glucagon-like-peptide-1 (GLP-1) (pg/ml)

  195 minutes

Study Arms (2)

Lean subjects

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.

Other: High-calorie meal

Obese subjects

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.

Other: High-calorie meal

Interventions

High-calorie meal OTHER

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

Lean subjects; Obese subjects

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Community sample. The obese group will be both a community and a clinical sample.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eleonora Seelig: lead
• Novartis: collaborator

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (28)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eleonora Seelig, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: July 22, 2020
• Study Start: May 14, 2020
• Primary Completion: February 20, 2021
• Study Completion: February 20, 2021
• Last Updated: March 23, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)