Overweight and ObesityGluco-FoodNCT04482738
Study of the Effects of Overfeeding on Glucocorticoids in Lean and Obese Subjects
An observational study of Overweight and Obesity, run by Eleonora Seelig at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- High-calorie meal
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 May 2020to 20 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Community sample. The obese group will be both a community and a clinical sample.
Who may be able to join
- Body mass index (BMI) >18,5 and <25 kg/m2
- BMI >30 kg/m2
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: The Acute Response of Glucocorticoids Upon Food Intake
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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- High-calorie meal
- Keywords
- obesity, overweight, cortisol, overfeeding, glucocorticoids
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-calorie mealOther
Intake of a high-calorie meal (2500-3000 calories) within 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: High-calorie meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pulsatile secretion of cortisol in response to a high-calorie meal (nmol/l)
Blood test
Measured: 195 minutes
Secondary outcomes (28)
Thyroid hormones (nmol/l)
Blood test
Measured: 195 minutes
Growth Hormone (mIU/l)
Blood test
Measured: 195 minutes
Catecholamines (pg/ml)
Blood test
Measured: 195 minutes
Adrenocorticotropic Hormone (ACTH) (pg/ml)
Blood test
Measured: 195 minutes
Glucagon-like-peptide-1 (GLP-1) (pg/ml)
Blood test
Measured: 195 minutes
Gastric inhibitory polypeptide (GIP) (pg/ml)
Blood test
Measured: 195 minutes
Peptide YY (PYY) (pg/ml)
Blood test
Measured: 195 minutes
Glucose (mmol/l)
Blood test
Measured: 195 minutes
Insulin (mIU/l)
Blood test
Measured: 195 minutes
C-Peptide (pmol/l)
Blood test
Measured: 195 minutes
Total cholesterol (mmol/l)
Blood test
Measured: 195 minutes
Low density lipoprotein (LDL)-cholesterol (mmol/l)
Blood test
Measured: 195 minutes
High density lipoprotein (HDL)-cholesterol (mmol/l)
Blood test
Measured: 195 minutes
Triglycerides (mmol/l)
Blood test
Measured: 195 minutes
Growth differentiation factor 15 (GDF15) (ng/l)
Blood test
Measured: 195 minutes
High-sensitive c-reactive Protein (hsCRP) (mg/l)
Blood test
Measured: 195 minutes
Interleukin-6 (IL-6) (pg/ml)
Blood test
Measured: 195 minutes
Interleukin-8 (IL-8) (pg/ml)
Blood test
Measured: 195 minutes
Interleukin-1 receptor Antagonist (IL-1Ra) (pg/ml)
Blood test
Measured: 195 minutes
Heart rate (bpm)
Heart rate variability analysis
Measured: 5 minutes
Blood pressure: diastolic and systolic blood pressure (mmHg)
Standard blood pressure monitor
Measured: 1 minute
Weight: kilogram body weight (kg)
Standard scale
Measured: 1 minute
Energy expenditure: basal metabolic rate
Indirect calorimetry
Measured: 200 minutes
Substrate utilisation: respiratory quotient
Indirect calorimetry
Measured: 200 minutes
Fat and lean mass (kg)
Body impedance analysis
Measured: 20 minutes
Total body water (l)
Body impedance analysis
Measured: 20 minutes
Appetite: visual analogue scale rating
Visual analogue scale
Measured: 3 hours
Stress: perceived stress Levels (0-56)
Perceived stress questionnaire
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start14 May 2020
- Primary completion20 Feb 2021
- Study completion20 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eleonora Seelig
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor-investigator, Eleonora Seelig, University Hospital, Basel, Switzerland
- Investigators
- Eleonora Seelig, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482738
- Sponsor's protocol ID
- 202000384
- Acronym
- Gluco-Food
- Status last verified
- Mar 2022
- First submitted
- 30 Mar 2020
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prospective Studies Collaboration; Whitlock G, Lewington S, Sherliker P, Clarke R, Emberson J, Halsey J, Qizilbash N, Collins R, Peto R. Body-mass index and cause-specific mortality in 900 000 adults: collaborative analyses of 57 prospective studies. Lancet. 2009 Mar 28;373(9669):1083-96. doi: 10.1016/S0140-6736(09)60318-4. Epub 2009 Mar 18.
PubMed 19299006van der Klaauw AA, Farooqi IS. The hunger genes: pathways to obesity. Cell. 2015 Mar 26;161(1):119-132. doi: 10.1016/j.cell.2015.03.008.
PubMed 25815990Vgontzas AN, Lin HM, Papaliaga M, Calhoun S, Vela-Bueno A, Chrousos GP, Bixler EO. Short sleep duration and obesity: the role of emotional stress and sleep disturbances. Int J Obes (Lond). 2008 May;32(5):801-9. doi: 10.1038/ijo.2008.4. Epub 2008 Feb 5.
PubMed 18253159de Guia RM, Rose AJ, Herzig S. Glucocorticoid hormones and energy homeostasis. Horm Mol Biol Clin Investig. 2014 Aug;19(2):117-28. doi: 10.1515/hmbci-2014-0021.
PubMed 25390020Russell G, Lightman S. The human stress response. Nat Rev Endocrinol. 2019 Sep;15(9):525-534. doi: 10.1038/s41574-019-0228-0. Epub 2019 Jun 27.
PubMed 31249398Ferrau F, Korbonits M. Metabolic Syndrome in Cushing's Syndrome Patients. Front Horm Res. 2018;49:85-103. doi: 10.1159/000486002. Epub 2018 Apr 5.
PubMed 29894989Livingstone DE, Grassick SL, Currie GL, Walker BR, Andrew R. Dysregulation of glucocorticoid metabolism in murine obesity: comparable effects of leptin resistance and deficiency. J Endocrinol. 2009 May;201(2):211-8. doi: 10.1677/JOE-09-0003. Epub 2009 Feb 17.
PubMed 19223399Livingstone DE, Jones GC, Smith K, Jamieson PM, Andrew R, Kenyon CJ, Walker BR. Understanding the role of glucocorticoids in obesity: tissue-specific alterations of corticosterone metabolism in obese Zucker rats. Endocrinology. 2000 Feb;141(2):560-3. doi: 10.1210/endo.141.2.7297.
PubMed 10650936Liu Y, Nakagawa Y, Wang Y, Li R, Li X, Ohzeki T, Friedman TC. Leptin activation of corticosterone production in hepatocytes may contribute to the reversal of obesity and hyperglycemia in leptin-deficient ob/ob mice. Diabetes. 2003 Jun;52(6):1409-16. doi: 10.2337/diabetes.52.6.1409.
PubMed 12765951Chalew S, Nagel H, Shore S. The hypothalamic-pituitary-adrenal axis in obesity. Obes Res. 1995 Jul;3(4):371-82. doi: 10.1002/j.1550-8528.1995.tb00163.x.
PubMed 8521154Marin P, Darin N, Amemiya T, Andersson B, Jern S, Bjorntorp P. Cortisol secretion in relation to body fat distribution in obese premenopausal women. Metabolism. 1992 Aug;41(8):882-6. doi: 10.1016/0026-0495(92)90171-6.
PubMed 1640867Duclos M, Corcuff JB, Etcheverry N, Rashedi M, Tabarin A, Roger P. Abdominal obesity increases overnight cortisol excretion. J Endocrinol Invest. 1999 Jun;22(6):465-71. doi: 10.1007/BF03343591.
PubMed 10435857Pasquali R, Cantobelli S, Casimirri F, Capelli M, Bortoluzzi L, Flamia R, Labate AM, Barbara L. The hypothalamic-pituitary-adrenal axis in obese women with different patterns of body fat distribution. J Clin Endocrinol Metab. 1993 Aug;77(2):341-6. doi: 10.1210/jcem.77.2.8393881.
PubMed 8393881Chalew SA, Lozano RA, Armour KM, Zadik Z, Kowarski AA. Reduction of plasma cortisol levels in childhood obesity. J Pediatr. 1991 Nov;119(5):778-80. doi: 10.1016/s0022-3476(05)80302-6. No abstract available.
PubMed 1941386Chalew SA, Nagel H, Burt D, Edwards CR. The integrated concentration of cortisone is reduced in obese children. J Pediatr Endocrinol Metab. 1997 May-Jun;10(3):287-90. doi: 10.1515/JPEM.1997.10.3.287.
PubMed 9388820
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Response of Glucocorticoids Upon Food Intake
- ClinicalTrials.gov ID
- NCT04482738
- Acronym / sponsor ID
- Gluco-Food / 202000384
- Conditions
- Overweight and Obesity
- Keywords
- obesity, overweight, cortisol, overfeeding, glucocorticoids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Eleonora SeeligUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 14 May 2020 (actual)
- Primary completion
- 20 Feb 2021 (actual)
- Study completion
- 20 Feb 2021 (actual)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean subjects | – | Other: High-calorie meal24 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. |
| Obese subjects | – | Other: High-calorie meal24 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample. The obese group will be both a community and a clinical sample.
Key inclusion criteria (2 listed)
- Body mass index (BMI) >18,5 and <25 kg/m2
- BMI >30 kg/m2
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-calorie mealIntake of a high-calorie meal (2500-3000 calories) within 15 minutes. | Other | Lean subjects, Obese subjects |
Primary outcome
Change in pulsatile secretion of cortisol in response to a high-calorie meal (nmol/l)
Time frame: 195 minutes
Blood test
28 secondary outcomes
Thyroid hormones (nmol/l)
Time frame: 195 minutes
Growth Hormone (mIU/l)
Time frame: 195 minutes
Catecholamines (pg/ml)
Time frame: 195 minutes
Adrenocorticotropic Hormone (ACTH) (pg/ml)
Time frame: 195 minutes
Glucagon-like-peptide-1 (GLP-1) (pg/ml)
Time frame: 195 minutes
Gastric inhibitory polypeptide (GIP) (pg/ml)
Time frame: 195 minutes
Peptide YY (PYY) (pg/ml)
Time frame: 195 minutes
Glucose (mmol/l)
Time frame: 195 minutes
Insulin (mIU/l)
Time frame: 195 minutes
C-Peptide (pmol/l)
Time frame: 195 minutes
Total cholesterol (mmol/l)
Time frame: 195 minutes
Low density lipoprotein (LDL)-cholesterol (mmol/l)
Time frame: 195 minutes
High density lipoprotein (HDL)-cholesterol (mmol/l)
Time frame: 195 minutes
Triglycerides (mmol/l)
Time frame: 195 minutes
Growth differentiation factor 15 (GDF15) (ng/l)
Time frame: 195 minutes
High-sensitive c-reactive Protein (hsCRP) (mg/l)
Time frame: 195 minutes
Interleukin-6 (IL-6) (pg/ml)
Time frame: 195 minutes
Interleukin-8 (IL-8) (pg/ml)
Time frame: 195 minutes
Interleukin-1 receptor Antagonist (IL-1Ra) (pg/ml)
Time frame: 195 minutes
Heart rate (bpm)
Time frame: 5 minutes
Blood pressure: diastolic and systolic blood pressure (mmHg)
Time frame: 1 minute
Weight: kilogram body weight (kg)
Time frame: 1 minute
Energy expenditure: basal metabolic rate
Time frame: 200 minutes
Substrate utilisation: respiratory quotient
Time frame: 200 minutes
Fat and lean mass (kg)
Time frame: 20 minutes
Total body water (l)
Time frame: 20 minutes
Appetite: visual analogue scale rating
Time frame: 3 hours
Stress: perceived stress Levels (0-56)
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Background: PubMed 19299006Prospective Studies Collaboration; Whitlock G, Lewington S, Sherliker P, Clarke R, Emberson J, Halsey J, Qizilbash N, Collins R, Peto R. Body-mass index and cause-specific mortality in 900 000 adults: collaborative analyses of 57 prospective studies. Lancet. 2009 Mar 28;373(9669):1083-96. doi: 10.1016/S0140-6736(09)60318-4. Epub 2009 Mar 18.
- Background: PubMed 25815990van der Klaauw AA, Farooqi IS. The hunger genes: pathways to obesity. Cell. 2015 Mar 26;161(1):119-132. doi: 10.1016/j.cell.2015.03.008.
- Background: PubMed 18253159Vgontzas AN, Lin HM, Papaliaga M, Calhoun S, Vela-Bueno A, Chrousos GP, Bixler EO. Short sleep duration and obesity: the role of emotional stress and sleep disturbances. Int J Obes (Lond). 2008 May;32(5):801-9. doi: 10.1038/ijo.2008.4. Epub 2008 Feb 5.
- Background: PubMed 25390020de Guia RM, Rose AJ, Herzig S. Glucocorticoid hormones and energy homeostasis. Horm Mol Biol Clin Investig. 2014 Aug;19(2):117-28. doi: 10.1515/hmbci-2014-0021.
- Background: PubMed 31249398Russell G, Lightman S. The human stress response. Nat Rev Endocrinol. 2019 Sep;15(9):525-534. doi: 10.1038/s41574-019-0228-0. Epub 2019 Jun 27.
- Background: PubMed 29894989Ferrau F, Korbonits M. Metabolic Syndrome in Cushing's Syndrome Patients. Front Horm Res. 2018;49:85-103. doi: 10.1159/000486002. Epub 2018 Apr 5.
- Background: PubMed 19223399Livingstone DE, Grassick SL, Currie GL, Walker BR, Andrew R. Dysregulation of glucocorticoid metabolism in murine obesity: comparable effects of leptin resistance and deficiency. J Endocrinol. 2009 May;201(2):211-8. doi: 10.1677/JOE-09-0003. Epub 2009 Feb 17.
- Background: PubMed 10650936Livingstone DE, Jones GC, Smith K, Jamieson PM, Andrew R, Kenyon CJ, Walker BR. Understanding the role of glucocorticoids in obesity: tissue-specific alterations of corticosterone metabolism in obese Zucker rats. Endocrinology. 2000 Feb;141(2):560-3. doi: 10.1210/endo.141.2.7297.
- Background: PubMed 12765951Liu Y, Nakagawa Y, Wang Y, Li R, Li X, Ohzeki T, Friedman TC. Leptin activation of corticosterone production in hepatocytes may contribute to the reversal of obesity and hyperglycemia in leptin-deficient ob/ob mice. Diabetes. 2003 Jun;52(6):1409-16. doi: 10.2337/diabetes.52.6.1409.
- Background: PubMed 8521154Chalew S, Nagel H, Shore S. The hypothalamic-pituitary-adrenal axis in obesity. Obes Res. 1995 Jul;3(4):371-82. doi: 10.1002/j.1550-8528.1995.tb00163.x.
- Background: PubMed 1640867Marin P, Darin N, Amemiya T, Andersson B, Jern S, Bjorntorp P. Cortisol secretion in relation to body fat distribution in obese premenopausal women. Metabolism. 1992 Aug;41(8):882-6. doi: 10.1016/0026-0495(92)90171-6.
- Background: PubMed 10435857Duclos M, Corcuff JB, Etcheverry N, Rashedi M, Tabarin A, Roger P. Abdominal obesity increases overnight cortisol excretion. J Endocrinol Invest. 1999 Jun;22(6):465-71. doi: 10.1007/BF03343591.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleonora Seelig, MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by Eleonora Seelig at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pulsatile secretion of cortisol in response to a high-calorie meal (nmol/l) (time frame: 195 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04482738, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.