ObesityNCT00688987
The Hypothalamic-Pituitary-Adrenal (HPA) Axis as an Effector System in Weight Regulation
A study testing Hydrocortisone and Isocaloric Diet in people with Obesity and Addison's Disease, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Replacing glucocorticoid in a dose dependent manner (including doses within the physiological range) to subjects with adrenal insufficiency will increase visceral fat accumulation independently of total fat mass. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Addison's Disease
- What is being tested?
- Hydrocortisone and Isocaloric Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2000to Aug 2004
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with complete adrenal failure as defined as spontaneous serum cortisol of levels less than 5 g/dl after 12 hours without glucocorticoid replacement and peak serum cortisol of < 5 g/dl 60 minutes after a 250 g ACTH stimulation test.
- Subjects who are at their usual weight (weight stable for at least 1 year)
- Subjects on stable replacement doses of any required hormone such as thyroid, sex hormones, mineralocorticoid replacement, growth hormone, and hydrocortisone for at least 6 months, and 4) have a normal body weight (BMI 19-27 kg/m2).
Who cannot join
- Possible confounders on body weight and insulin resistance
- Age less than 18 to exclude those who might be experiencing alterations in cortisol production or weight as a result of adolescent growth.
- Subjects who exercise > 30 minutes/day, 3 times a week.
- Smokers.
- Heavy alcohol drinkers (> 2 drinks/ day).
- Subjects with medical diagnosis including diabetes, heart disease, and cancer.
- Subjects with psychiatric illness (i.e., depression, psychosis, bipolar, schizophrenia; or are taking medications for these disorders).
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Cortisol, Central Obesity, and Insulin Resistance: Long Term Studies in Addison's Patients
Replacing glucocorticoid in a dose dependent manner (including doses within the physiological range) to subjects with adrenal insufficiency will increase visceral fat accumulation independently of total fat mass.
Read the detailed description
To measure total fat mass by DEXA scan, central (visceral) fat accumulation, insulin sensitivity by FSIVGTT, lipid levels, and adipocyte gene expression in subjects with AI receiving increasing doses of hydrocortisone replacement (15 mg, 25 mg, and 40 mg per day in split doses) for 4-months at a time during ad-lib feeding.
- Conditions
- Obesity, Addison's Disease
- Being tested
- Hydrocortisone, Isocaloric Diet
- Medical subject headings
- Obesity, Addison Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Subjects will receive in random order daily (split) dosing of hydrocortisone: a low dose of 15 mg (10 in AM, 5 in PM); a medium dose of 25 mg (15 in AM, 10 in PM) and high dose of 40 mg (30 in AM, 10 in PM) for 4 months.
Isocaloric DietDietary supplement
Also called Weight stable diet
Subjects will eat an isocaloric diet for 4 weeks while taking hydrocortisone
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Subjects with AI will be randomized to each of three doses of hydrocortisone for 4 months on each dose. Receives: Drug: Hydrocortisone |
| 2 | Active comparator | isocaloric diet Receives: Dietary Supplement: Isocaloric Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amounts of intra-abdominal fat and total fat at the end of the treatment period for each cortisol dose.
Measured: After 4 months on each dose
Secondary outcomes (1)
Fasting Lipid levels, fat mass by DEXA, post-heparin lipase activity, insulin sensitivity, and fat biopsy
Measured: After 4-months on each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startAug 2000
- Primary completionJul 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688987
- Sponsor's protocol ID
- eIRB 545
- Other IDs
- OCTRI #711
- Status last verified
- Jun 2008
- First submitted
- 30 May 2008
- Last updated
- 5 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortisol, Central Obesity, and Insulin Resistance: Long Term Studies in Addison's Patients
- ClinicalTrials.gov ID
- NCT00688987
- Acronym / sponsor ID
- eIRB 545
- Conditions
- Obesity, Addison's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Aug 2000
- Primary completion
- Jul 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 3 Jun 2008 (estimated)
- 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.
Replacing glucocorticoid in a dose dependent manner (including doses within the physiological range) to subjects with adrenal insufficiency will increase visceral fat accumulation independently of total fat mass.
Detailed description
To measure total fat mass by DEXA scan, central (visceral) fat accumulation, insulin sensitivity by FSIVGTT, lipid levels, and adipocyte gene expression in subjects with AI receiving increasing doses of hydrocortisone replacement (15 mg, 25 mg, and 40 mg per day in split doses) for 4-months at a time during ad-lib feeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: HydrocortisoneSubjects with AI will be randomized to each of three doses of hydrocortisone for 4 months on each dose. |
| 2 | Active comparator | Dietary Supplement: Isocaloric Dietisocaloric diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with complete adrenal failure as defined as spontaneous serum cortisol of levels less than 5 g/dl after 12 hours without glucocorticoid replacement and peak serum cortisol of < 5 g/dl 60 minutes after a 250 g ACTH stimulation test.
- Subjects who are at their usual weight (weight stable for at least 1 year)
- Subjects on stable replacement doses of any required hormone such as thyroid, sex hormones, mineralocorticoid replacement, growth hormone, and hydrocortisone for at least 6 months, and 4) have a normal body weight (BMI 19-27 kg/m2).
Key exclusion criteria (7 listed)
- Possible confounders on body weight and insulin resistance
- Age less than 18 to exclude those who might be experiencing alterations in cortisol production or weight as a result of adolescent growth.
- Subjects who exercise > 30 minutes/day, 3 times a week.
- Smokers.
- Heavy alcohol drinkers (> 2 drinks/ day).
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 |
|---|---|---|
| HydrocortisoneSubjects will receive in random order daily (split) dosing of hydrocortisone: a low dose of 15 mg (10 in AM, 5 in PM); a medium dose of 25 mg (15 in AM, 10 in PM) and high dose of 40 mg (30 in AM, 10 in PM) for 4 months. | Drug | 1 |
| Isocaloric DietAlso: Weight stable dietSubjects will eat an isocaloric diet for 4 weeks while taking hydrocortisone | Dietary supplement | 2 |
Primary outcome
Amounts of intra-abdominal fat and total fat at the end of the treatment period for each cortisol dose.
Time frame: After 4 months on each dose
1 secondary outcome
Fasting Lipid levels, fat mass by DEXA, post-heparin lipase activity, insulin sensitivity, and fat biopsy
Time frame: After 4-months on each dose
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 5 Jun 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrocortisone and Isocaloric Diet in people with Obesity and Addison's Disease, run by Oregon Health and Science University at 1 site in United States.
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 3 inclusion and 7 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 5 Jun 2008. 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 United States. 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?
Amounts of intra-abdominal fat and total fat at the end of the treatment period for each cortisol dose. (time frame: After 4 months on each dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2008.