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Study of the Effects of Overfeeding on Glucocorticoids in Lean and Obese Subjects (Gluco-Food)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04482738
Recruitment Status : Completed
First Posted : July 22, 2020
Last Update Posted : March 23, 2022
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Eleonora Seelig, University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date March 30, 2020
First Posted Date July 22, 2020
Last Update Posted Date March 23, 2022
Actual Study Start Date May 14, 2020
Actual Primary Completion Date February 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 17, 2020)
Change in pulsatile secretion of cortisol in response to a high-calorie meal (nmol/l) [ Time Frame: 195 minutes ]
Blood test
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 17, 2020)
  • Thyroid hormones (nmol/l) [ Time Frame: 195 minutes ]
    Blood test
  • Growth Hormone (mIU/l) [ Time Frame: 195 minutes ]
    Blood test
  • Catecholamines (pg/ml) [ Time Frame: 195 minutes ]
    Blood test
  • Adrenocorticotropic Hormone (ACTH) (pg/ml) [ Time Frame: 195 minutes ]
    Blood test
  • Glucagon-like-peptide-1 (GLP-1) (pg/ml) [ Time Frame: 195 minutes ]
    Blood test
  • Gastric inhibitory polypeptide (GIP) (pg/ml) [ Time Frame: 195 minutes ]
    Blood test
  • Peptide YY (PYY) (pg/ml) [ Time Frame: 195 minutes ]
    Blood test
  • Glucose (mmol/l) [ Time Frame: 195 minutes ]
    Blood test
  • Insulin (mIU/l) [ Time Frame: 195 minutes ]
    Blood test
  • C-Peptide (pmol/l) [ Time Frame: 195 minutes ]
    Blood test
  • Total cholesterol (mmol/l) [ Time Frame: 195 minutes ]
    Blood test
  • Low density lipoprotein (LDL)-cholesterol (mmol/l) [ Time Frame: 195 minutes ]
    Blood test
  • High density lipoprotein (HDL)-cholesterol (mmol/l) [ Time Frame: 195 minutes ]
    Blood test
  • Triglycerides (mmol/l) [ Time Frame: 195 minutes ]
    Blood test
  • Growth differentiation factor 15 (GDF15) (ng/l) [ Time Frame: 195 minutes ]
    Blood test
  • High-sensitive c-reactive Protein (hsCRP) (mg/l) [ Time Frame: 195 minutes ]
    Blood test
  • Interleukin-6 (IL-6) (pg/ml) [ Time Frame: 195 minutes ]
    Blood test
  • Interleukin-8 (IL-8) (pg/ml) [ Time Frame: 195 minutes ]
    Blood test
  • Interleukin-1 receptor Antagonist (IL-1Ra) (pg/ml) [ Time Frame: 195 minutes ]
    Blood test
  • Heart rate (bpm) [ Time Frame: 5 minutes ]
    Heart rate variability analysis
  • Blood pressure: diastolic and systolic blood pressure (mmHg) [ Time Frame: 1 minute ]
    Standard blood pressure monitor
  • Weight: kilogram body weight (kg) [ Time Frame: 1 minute ]
    Standard scale
  • Energy expenditure: basal metabolic rate [ Time Frame: 200 minutes ]
    Indirect calorimetry
  • Substrate utilisation: respiratory quotient [ Time Frame: 200 minutes ]
    Indirect calorimetry
  • Fat and lean mass (kg) [ Time Frame: 20 minutes ]
    Body impedance analysis
  • Total body water (l) [ Time Frame: 20 minutes ]
    Body impedance analysis
  • Appetite: visual analogue scale rating [ Time Frame: 3 hours ]
    Visual analogue scale
  • Stress: perceived stress Levels (0-56) [ Time Frame: 5 minutes ]
    Perceived stress questionnaire
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of the Effects of Overfeeding on Glucocorticoids in Lean and Obese Subjects
Official Title The Acute Response of Glucocorticoids Upon Food Intake
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood samples
Sampling Method Non-Probability Sample
Study Population Community sample. The obese group will be both a community and a clinical sample.
Condition Overweight and Obesity
Intervention Other: High-calorie meal
Intake of a high-calorie meal (2500-3000 calories) within 15 minutes.
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: Other: High-calorie meal
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 17, 2020)
36
Original Estimated Enrollment Same as current
Actual Study Completion Date February 20, 2021
Actual Primary Completion Date February 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT04482738
Other Study ID Numbers 202000384
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Eleonora Seelig, University Hospital, Basel, Switzerland
Original Responsible Party Same as current
Current Study Sponsor Eleonora Seelig
Original Study Sponsor Same as current
Collaborators Novartis
Investigators
Principal Investigator: Eleonora Seelig, MD University Hospital, Basel, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date March 2022