Primary AldosteronismNCT00173082
Metabolic Syndrome and Insulin Resistance in Primary Aldosteronism
An observational study of Primary Aldosteronism, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Primary aldosteronism (PA) is occasionally associated with impaired glucose tolerance. Glucose intolerance, in general metabolic syndrome is caused by suppression of insulin release from the pancreas and suppression of insulin sensitivity of the target tissues. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Aldosteronism
- What is being tested?
- Glucose tolerance test
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2005to Jul 2008
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18 years old
- Aldosteronism patients
Who cannot join
- Patients with pregnancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Vincent Wu, MD, +886-2-23562082, walt-wu@yahoo.com.tw
About this study
Primary aldosteronism (PA) is occasionally associated with impaired glucose tolerance. Glucose intolerance, in general metabolic syndrome is caused by suppression of insulin release from the pancreas and suppression of insulin sensitivity of the target tissues. Several studies have suggested that impaired glucose tolerance in primary aldosteronism is due to an inability of the beta cells to release insulin by potassium depletion. It was suggested glucose intolerance in PA is caused by the suppression of insulin release related to hypopotassemia and compensatory increase of insulin sensitivity is observed in PA. The increased insulin secretory capacity associated with correction of negative potassium balance may account for the increase in plasma leptin after curing primary aldosteronism. The conclusion with respect to the possible causal relationship between diabetes mellitus (DM) and PA, however, can be obtained after the evaluation of the effect of surgical /pharmacological treatment of PA.
Read the detailed description
Primary aldosteronism (PA) is occasionally associated with impaired glucose tolerance. Glucose intolerance, in general metabolic syndrome is caused by suppression of insulin release from the pancreas and suppression of insulin sensitivity of the target tissues. Several studies have suggested that impaired glucose tolerance in primary aldosteronism is due to an inability of the beta cells to release insulin by potassium depletion. It was suggested glucose intolerance in PA is caused by the suppression of insulin release related to hypopotassemia and compensatory increase of insulin sensitivity is observed in PA. The increased insulin secretory capacity associated with correction of negative potassium balance may account for the increase in plasma leptin after curing primary aldosteronism. The conclusion with respect to the possible causal relationship between DM and PA, however, can be obtained after the evaluation of the effect of surgical /pharmacological treatment of PA. From July 2005 to July 2008, patients with primary aldosteronism, hospitalized for a comprehensive study of the subtypes of primary aldosteronism before operation will receive informed consent about the insulin sensitivity test. In the present study, we measured insulin sensitivity via the ability to release insulin by the 75 g oral glucose tolerance test (OGTT) in PA to clarify the mechanisms of glucose intolerance in PA. Seventy-five gram OGTT was performed in PA before and after adrenalectomy. Within one minute, 75 g of glucose dissolved in 200 cc water was ingested. Venous blood samples were drawn at 0, 60, 120 minutes for determination of plasma glucose and plasma insulin levels. Serum potassium levels were measures at 0 minutes. Furthermore, the adipokines, HOMA, QUICKI, leptin, adiponectin, homocystine, C-reactive protein, proinflammatory cytokine and adhesion molecules were also measured.
- Conditions
- Primary Aldosteronism
- Being tested
- Glucose tolerance test
- Keywords
- primary aldosteronism, Insulin resistance, Metabolic syndrome, OGTT
- Medical subject headings
- Hyperaldosteronism, Insulin Resistance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose tolerance testProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 2005
- Study completionJul 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kwan-Dun Wu, MD, PhD, Study chair, National Taiwan University HospitalVin-cent Wu, MD, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00173082
- Sponsor's protocol ID
- 9461700402
- Status last verified
- Nov 2007
- First submitted
- 12 Sep 2005
- Last updated
- 29 Nov 2007
- Results posted
- No
Publications
Corry DB, Tuck ML. The effect of aldosterone on glucose metabolism. Curr Hypertens Rep. 2003 Apr;5(2):106-9. doi: 10.1007/s11906-003-0065-2.
PubMed 12642008Widimsky J Jr, Strauch B, Sindelka G, Skrha J. Can primary hyperaldosteronism be considered as a specific form of diabetes mellitus? Physiol Res. 2001;50(6):603-7.
PubMed 11829322Kreze A Sr, Kreze-Spirova E, Mikulecky M. Diabetes mellitus in primary aldosteronism. Bratisl Lek Listy. 2000;101(4):187-90.
PubMed 10914461
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Syndrome and Insulin Resistance in Primary Aldosteronism
- ClinicalTrials.gov ID
- NCT00173082
- Acronym / sponsor ID
- 9461700402
- Conditions
- Primary Aldosteronism
- Keywords
- primary aldosteronism, Insulin resistance, Metabolic syndrome, OGTT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jun 2005
- Study completion
- Jul 2008 (estimated)
- First posted
- 15 Sep 2005 (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.
Primary aldosteronism (PA) is occasionally associated with impaired glucose tolerance. Glucose intolerance, in general metabolic syndrome is caused by suppression of insulin release from the pancreas and suppression of insulin sensitivity of the target tissues. Several studies have suggested that impaired glucose tolerance in primary aldosteronism is due to an inability of the beta cells to release insulin by potassium depletion. It was suggested glucose intolerance in PA is caused by the suppression of insulin release related to hypopotassemia and compensatory increase of insulin sensitivity is observed in PA. The increased insulin secretory capacity associated with correction of negative potassium balance may account for the increase in plasma leptin after curing primary aldosteronism. The conclusion with respect to the possible causal relationship between diabetes mellitus (DM) and PA, however, can be obtained after the evaluation of the effect of surgical /pharmacological treatment of PA.
Detailed description
Primary aldosteronism (PA) is occasionally associated with impaired glucose tolerance. Glucose intolerance, in general metabolic syndrome is caused by suppression of insulin release from the pancreas and suppression of insulin sensitivity of the target tissues. Several studies have suggested that impaired glucose tolerance in primary aldosteronism is due to an inability of the beta cells to release insulin by potassium depletion. It was suggested glucose intolerance in PA is caused by the suppression of insulin release related to hypopotassemia and compensatory increase of insulin sensitivity is observed in PA. The increased insulin secretory capacity associated with correction of negative potassium balance may account for the increase in plasma leptin after curing primary aldosteronism. The conclusion with respect to the possible causal relationship between DM and PA, however, can be obtained after the evaluation of the effect of surgical /pharmacological treatment of PA. From July 2005 to July 2008, patients with primary aldosteronism, hospitalized for a comprehensive study of the subtypes of primary aldosteronism before operation will receive informed consent about the insulin sensitivity test. In the present study, we measured insulin sensitivity via the ability to release insulin by the 75 g oral glucose tolerance test (OGTT) in PA to clarify the mechanisms of glucose intolerance in PA. Seventy-five gram OGTT was performed in PA before and after adrenalectomy. Within one minute, 75 g of glucose dissolved in 200 cc water was ingested. Venous blood samples were drawn at 0, 60, 120 minutes for determination of plasma glucose and plasma insulin levels. Serum potassium levels were measures at 0 minutes. Furthermore, the adipokines, HOMA, QUICKI, leptin, adiponectin, homocystine, C-reactive protein, proinflammatory cytokine and adhesion molecules were also measured.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age more than 18 years old
- Aldosteronism patients
Key exclusion criteria (1 listed)
- Patients with pregnancy
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 |
|---|---|---|
| Glucose tolerance test | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2007.
- Background: PubMed 12642008Corry DB, Tuck ML. The effect of aldosterone on glucose metabolism. Curr Hypertens Rep. 2003 Apr;5(2):106-9. doi: 10.1007/s11906-003-0065-2.
- Background: PubMed 11829322Widimsky J Jr, Strauch B, Sindelka G, Skrha J. Can primary hyperaldosteronism be considered as a specific form of diabetes mellitus? Physiol Res. 2001;50(6):603-7.
- Background: PubMed 10914461Kreze A Sr, Kreze-Spirova E, Mikulecky M. Diabetes mellitus in primary aldosteronism. Bratisl Lek Listy. 2000;101(4):187-90.
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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.
Kwan-Dun Wu, MD, PhD study chair
National Taiwan University Hospital
Vin-cent Wu, MD study director
National Taiwan University Hospital
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 Primary Aldosteronism, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 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: status not confirmed, as of the sponsor's last update on 29 Nov 2007. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vin-cent Wu, MD (+886-2-23562082, kdw@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00173082, which also lists 3 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 29 Nov 2007.