Metabolic SyndromeNCT00720616
Low Dose Growth Hormone Treatment in Subjects With Metabolic Syndrome.
A study testing Norditropin in people with Metabolic Syndrome, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Study hypothesis: Low dose growth hormone (GH), through its generation of free 'bioavailable' insulin-like growth factor (IGF)-I, can improve insulin sensitivity and the metabolic profile of subjects with metabolic syndrome. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Norditropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Dec 2012
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- Age 21 to 65 years
- Body mass index between 25 to 40 kg/m2
- Diagnosis of MBS based on the consensus statement by the International Diabetes Federation i.e., central obesity defined by waist circumference in men of ≥ 94 cm and in women of ≥ 80 cm plus two other components from the following: 1) dyslipidemia (triglyceride levels ≥ 150 mg/dl or on therapy and/or HDL in men of < 40 mg/dl and in women of < 50 mg/dl or on therapy); 2) hypertension (blood pressure ≥ 130/85 mmHg or on therapy and 3) hyperglycemia (fasting plasma glucose ≥ 100 mg/dl or on therapy)
- Stable weight and diet for at least 6 months prior to study entry
- Normal thyroid function
- Normal renal and hepatic function
- Able to self administer GH/Placebo injections
Who cannot join
- Inability to comply with study requirements
- Body mass index < 30 kg/m2 and > 40 kg/m2 (patients with body mass index > 40 kg/m2 are excluded because they will not fit into the MRS scanner)
- Untreated hypothyroidism or hyperthyroidism
- Anemia from any cause
- Known diabetes mellitus
- Patients with an increased risk of venous thrombosis or previous history of recurrent venous thrombosis
Show all 17Show fewer
- Patient on any insulin-sensitizers (e.g., Metformin, Rosiglitazone, Pioglitazone) within 30 days of screening assessment
- Patient on any anti-androgens (e.g., Spironolactone, Cyproterone acetate, Flutamide, Finasteride) within 30 days of screening assessment
- Patient with other concurrent illnesses
- Pregnant (positive pregnancy test) prior enrollment in the study or planning to conceive whilst participating in the study
- Emotional/social instability likely to prejudice study completion
- Previous history of known malignancy
- Recurrent or severe unexplained hypoglycemia
- Known or suspected drug/alcohol abuse
- Patient with any metals in the body
- Any other condition/s that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: Effects of a Fixed Low Dose Growth Hormone Therapy on Insulin Sensitivity, Metabolic Profile, Adipocyte IGF-I and Insulin Signalling, Intramyocellular and Intrahepatic Lipids, and Cortisol Metabolism in Subjects With Metabolic Syndrome.
Study hypothesis:
Low dose growth hormone (GH), through its generation of free 'bioavailable' insulin-like growth factor (IGF)-I, can improve insulin sensitivity and the metabolic profile of subjects with metabolic syndrome.
Read more
Study aims:
The purpose of this study is to determine the mechanism of how low dose GH treatment affects the body's sensitivity to insulin actions and whether this low GH dose can affect the body's handling of steroid hormone levels (cortisol clearance) and fat deposition in subjects with metabolic syndrome.
Study design: Subjects that satisfy the criteria of metabolic syndrome (central obesity, treated or untreated high blood pressure, high cholesterol and impaired fasting glucose levels) will be invited to participate in this study. The subjects will be assessed at the initial visit to ascertain their suitability before further participation in the study. If eligible, an equal number of men and women will be randomized (like a flip of a coin) to receive either daily low dose GH or placebo injections first for 12 weeks, before exchanging over for another 12 weeks of treatment after a 4-week washout period. Before, during and after treatment, the subjects will be assessed at frequently with blood tests, scans and fat biopsies. During the study, the subjects will be studied 4 times at the Oregon Clinical and Translational Research Institute (OCTRI). At the first, second and final visit, testing will include scans to measure the amount of whole body fat and fat in the stomach area, muscle, and liver; blood tests to measure levels of cortisol, and fat tissue (taken from a biopsy) analysis to measure the density of insulin-like growth factor-I (a hormone stimulated by growth hormone in the body) in fat; whereas blood tests to examine how well insulin works in the body (insulin sensitivity) will be collected at all visits of the study.
Read the detailed description
The study will be a double-blinded randomized placebo-controlled cross-over study. Thirty subjects will be screened for eligibility initially, and the first 12 eligible subjects will be enrolled. Six subjects will be randomized to receive the low GH dose (0.1 mg/day) treatment and 6 subjects to receive Placebo treatment for 12 weeks, exchanging their treatment for a further 12 weeks after a 4-week washout period. The study drugs will be stored at the Oregon Health and Science University (OHSU) Research Pharmacy and following randomization, the subjects will be taught by either the Principal Investigator or one of our Endocrine Nurses to self-administer the injections using Norditropin/Placebo vials and insulin syringes into the abdomen at 2200h. Randomization for treatment assignment will be performed by an investigator not directly involved in the patients' recruitment, treatment and follow-up care. The randomization process will be performed by computerized pre-assigned random codes by blocks, stratified by age and examined for possible differences in body mass index. During their in-patient stay at the Oregon Clinical and Translational Research Institute (OCTRI) at OHSU, subjects will only be allowed to eat the food provided to them by the OCTRI.
Initial Screening Assessment (outpatient)
The following assessments will be performed:
- Written informed consent
- Demographics (demographic information including the subject's birth date, and race)
- Physical exam and medical history
- Previous/significant medical history
- Concomitant medication review
- Vital signs, e.g., pulse and blood pressure measurements
- Height, weight and waist circumference
- Laboratory findings, e.g. CBC, electrolytes, and fasting glucose levels
Visit 1, Baseline Assessment for the First Treatment Phase (in-patient)
The following is a description of the assessments that will be performed after consent is obtained:
- Physical exam and medical history
- Vital signs, e.g., pulse and blood pressure measurements
- Height and weight
- Waist circumference measurement
- Concomitant medication review
- Urine pregnancy test for female child-bearing subjects
- Fasting blood assessments, e.g., hemoglobin, glucose, insulin, C-peptide, serum total and free IGF-I, IGFBP-3, C-reactive protein, non-esterified fatty acids (NEFAs), adiponectin, and ghrelin
- A 3-hour one-step hyperinsulinemic euglycemic clamp
- MRS and DEXA scans
- Cortisol clearance rate assessments
- Fat biopsy
- Randomization to GH or Placebo
- Teach GH or Placebo self-administration
Visit 2, Final Assessment for the First Treatment Phase (Week 12 +/- 1 week) (outpatient)
The following is a description of the assessments that will be performed at the end of the first treatment phase with either GH or Placebo. Subjects will also be monitored for safety with the collection of the following:
- Physical exam and medical history
- Vital signs, e.g. pulse and blood pressure measurements
- Height and weight
- Waist circumference measurement
- Concomitant medication review
- Adverse event recording
- Urine pregnancy test for female child-bearing subjects
- Fasting blood assessments, e.g., hemoglobin, glucose, insulin, C-peptide, serum total and free IGF-I, IGFBP-3, C-reactive protein, non-esterified fatty acids (NEFAs), adiponectin, and ghrelin
- A 3-hour one-step hyperinsulinemic euglycemic clamp
- MRS and DEXA scans
- Cortisol clearance rate assessments
- Fat biopsy
Washout Period and Crossover after the first treatment phase with GH or Placebo, the subjects will have a 4-week washout period and the treatment will be crossed over for another 12-week treatment phase with either GH or Placebo. During this time, the subjects will be advised to maintain a stable diet and weight.
Visit 3, Baseline Assessment for the Second Treatment Phase (Week 16 +/- 1 week) (as outpatient)
The following is a description of the assessments that will be performed:
- Physical exam and medical history
- Vital signs, e.g., pulse and blood pressure measurements
- Height and weight
- Waist circumference measurement
- Concomitant medication review
- Urine pregnancy test for female child-bearing subjects
- Fasting blood assessments, e.g., hemoglobin, glucose, insulin, C-peptide, serum total and free IGF-I, IGFBP-3, C-reactive protein, non-esterified fatty acids (NEFAs), adiponectin, and ghrelin
- A 3-hour one-step hyperinsulinemic euglycemic clamp
- MRS and DEXA scans
- Cortisol clearance rate assessments
- Fat biopsy
- Treatment exchanged to Placebo or GH
Visit 4, Final Assessment for the Second Treatment Phase (Week 28 +/- 1 week) (as inpatient)
The following is a description of the assessments that will be performed at the end of the second treatment phase with either GH or Placebo. Subjects will also be monitored for safety with the collection of the following:
- Physical exam and medical history
- Vital signs, e.g., pulse and blood pressure measurements
- Height and weight
- Waist circumference measurement
- Concomitant medication review
- Urine pregnancy test for female child-bearing subjects
- Fasting blood assessments, e.g., hemoglobin, glucose, insulin, C-peptide, serum total and free IGF-I, IGFBP-3, C-reactive protein, non-esterified fatty acids (NEFAs), adiponectin, and ghrelin
- A 3-hour one-step hyperinsulinemic euglycemic clamp
- MRS and DEXA scans
- Cortisol clearance rate assessments
- Fat biopsy
Because of the potentially long duration of Visits 1, 2 and 4, the studies can either be divided into two separate admissions upon prior arrangement or can be done all at once with one admission, depending on the subject's wishes and schedule.
- Conditions
- Metabolic Syndrome
- Being tested
- Norditropin
- Keywords
- Growth hormone, Metabolic syndrome, Insulin sensitivity
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorditropinDrug
Also called Growth hormone, metabolic syndrome, insulin sensitivity
Norditropin 0.1 mg/day self-administered once a day subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Growth hormone or Placebo 0.1 mg/day self-administrated once a day. Receives: Drug: Norditropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in insulin sensitivity, and adipocyte IGF-I and insulin receptor signaling.
Measured: 24 months
Secondary outcomes (1)
Changes in body composition, cortisol production rates, and muscle and liver intramyocellular content.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2008 (estimated)
- Study startOct 2010
- Primary completionOct 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Yuen, Oregon Health and Science University
- Investigators
- Kevin C. Yuen, MRCP(UK), MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720616
- Sponsor's protocol ID
- IRB4481
- Status last verified
- Feb 2013
- First submitted
- 21 Jul 2008
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Yuen K, Wareham N, Frystyk J, Hennings S, Mitchell J, Fryklund L, Dunger D. Short-term low-dose growth hormone administration in subjects with impaired glucose tolerance and the metabolic syndrome: effects on beta-cell function and post-load glucose tolerance. Eur J Endocrinol. 2004 Jul;151(1):39-45. doi: 10.1530/eje.0.1510039.
PubMed 15248820
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Fixed Low Dose Growth Hormone Therapy on Insulin Sensitivity, Metabolic Profile, Adipocyte IGF-I and Insulin Signalling, Intramyocellular and Intrahepatic Lipids, and Cortisol Metabolism in Subjects With Metabolic Syndrome.
- ClinicalTrials.gov ID
- NCT00720616
- Acronym / sponsor ID
- IRB4481
- Conditions
- Metabolic Syndrome
- Keywords
- Growth hormone, Metabolic syndrome, Insulin sensitivity
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 23 Jul 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.
Study hypothesis:
Low dose growth hormone (GH), through its generation of free 'bioavailable' insulin-like growth factor (IGF)-I, can improve insulin sensitivity and the metabolic profile of subjects with metabolic syndrome.
Study aims:
The purpose of this study is to determine the mechanism of how low dose GH treatment affects the body's sensitivity to insulin actions and whether this low GH dose can affect the body's handling of steroid hormone levels (cortisol clearance) and fat deposition in subjects with metabolic syndrome.
Study design: Subjects that satisfy the criteria of metabolic syndrome (central obesity, treated or untreated high blood pressure, high cholesterol and impaired fasting glucose levels) will be invited to participate in this study. The subjects will be assessed at the initial visit to ascertain their suitability before further participation in the study. If eligible, an equal number of men and women will be randomized (like a flip of a coin) to receive either daily low dose GH or placebo injections first for 12 weeks, before exchanging over for another 12 weeks of treatment after a 4-week washout period. Before, during and after treatment, the subjects will be assessed at frequently with blood tests, scans and fat biopsies. During the study, the subjects will be studied 4 times at the Oregon Clinical and Translational Research Institute (OCTRI). At the first, second and final visit, testing will include scans to measure the amount of whole body fat and fat in the stomach area, muscle, and liver; blood tests to measure levels of cortisol, and fat tissue (taken from a biopsy) analysis to measure the density of insulin-like growth factor-I (a hormone stimulated by growth hormone in the body) in fat; whereas blood tests to examine how well insulin works in the body (insulin sensitivity) will be collected at all visits of the study.
Detailed description
The study will be a double-blinded randomized placebo-controlled cross-over study. Thirty subjects will be screened for eligibility initially, and the first 12 eligible subjects will be enrolled. Six subjects will be randomized to receive the low GH dose (0.1 mg/day) treatment and 6 subjects to receive Placebo treatment for 12 weeks, exchanging their treatment for a further 12 weeks after a 4-week washout period. The study drugs will be stored at the Oregon Health and Science University (OHSU) Research Pharmacy and following randomization, the subjects will be taught by either the Principal Investigator or one of our Endocrine Nurses to self-administer the injections using Norditropin/Placebo vials and insulin syringes into the abdomen at 2200h. Randomization for treatment assignment will be performed by an investigator not directly involved in the patients' recruitment, treatment and follow-up care. The randomization process will be performed by computerized pre-assigned random codes by blocks, stratified by age and examined for possible differences in body mass index. During their in-patient stay at the Oregon Clinical and Translational Research Institute (OCTRI) at OHSU, subjects will only be allowed to eat the food provided to them by the OCTRI.
Initial Screening Assessment (outpatient)
The following assessments will be performed:
- Written informed consent
- Demographics (demographic information including the subject's birth date, and race)
- Physical exam and medical history
- Previous/significant medical history
- Concomitant medication review
- Vital signs, e.g., pulse and blood pressure measurements
- Height, weight and waist circumference
- Laboratory findings, e.g. CBC, electrolytes, and fasting glucose levels
Visit 1, Baseline Assessment for the First Treatment Phase (in-patient)
The following is a description of the assessments that will be performed after consent is obtained:
- Physical exam and medical history
- Vital signs, e.g., pulse and blood pressure measurements
- Height and weight
- Waist circumference measurement
- Concomitant medication review
- Urine pregnancy test for female child-bearing subjects
- Fasting blood assessments, e.g., hemoglobin, glucose, insulin, C-peptide, serum total and free IGF-I, IGFBP-3, C-reactive protein, non-esterified fatty acids (NEFAs), adiponectin, and ghrelin
- A 3-hour one-step hyperinsulinemic euglycemic clamp
- MRS and DEXA scans
- Cortisol clearance rate assessments
- Fat biopsy
- Randomization to GH or Placebo
- Teach GH or Placebo self-administration
Visit 2, Final Assessment for the First Treatment Phase (Week 12 +/- 1 week) (outpatient)
The following is a description of the assessments that will be performed at the end of the first treatment phase with either GH or Placebo. Subjects will also be monitored for safety with the collection of the following:
- Physical exam and medical history
- Vital signs, e.g. pulse and blood pressure measurements
- Height and weight
- Waist circumference measurement
- Concomitant medication review
- Adverse event recording
- Urine pregnancy test for female child-bearing subjects
- Fasting blood assessments, e.g., hemoglobin, glucose, insulin, C-peptide, serum total and free IGF-I, IGFBP-3, C-reactive protein, non-esterified fatty acids (NEFAs), adiponectin, and ghrelin
- A 3-hour one-step hyperinsulinemic euglycemic clamp
- MRS and DEXA scans
- Cortisol clearance rate assessments
- Fat biopsy
Washout Period and Crossover after the first treatment phase with GH or Placebo, the subjects will have a 4-week washout period and the treatment will be crossed over for another 12-week treatment phase with either GH or Placebo. During this time, the subjects will be advised to maintain a stable diet and weight.
Visit 3, Baseline Assessment for the Second Treatment Phase (Week 16 +/- 1 week) (as outpatient)
The following is a description of the assessments that will be performed:
- Physical exam and medical history
- Vital signs, e.g., pulse and blood pressure measurements
- Height and weight
- Waist circumference measurement
- Concomitant medication review
- Urine pregnancy test for female child-bearing subjects
- Fasting blood assessments, e.g., hemoglobin, glucose, insulin, C-peptide, serum total and free IGF-I, IGFBP-3, C-reactive protein, non-esterified fatty acids (NEFAs), adiponectin, and ghrelin
- A 3-hour one-step hyperinsulinemic euglycemic clamp
- MRS and DEXA scans
- Cortisol clearance rate assessments
- Fat biopsy
- Treatment exchanged to Placebo or GH
Visit 4, Final Assessment for the Second Treatment Phase (Week 28 +/- 1 week) (as inpatient)
The following is a description of the assessments that will be performed at the end of the second treatment phase with either GH or Placebo. Subjects will also be monitored for safety with the collection of the following:
- Physical exam and medical history
- Vital signs, e.g., pulse and blood pressure measurements
- Height and weight
- Waist circumference measurement
- Concomitant medication review
- Urine pregnancy test for female child-bearing subjects
- Fasting blood assessments, e.g., hemoglobin, glucose, insulin, C-peptide, serum total and free IGF-I, IGFBP-3, C-reactive protein, non-esterified fatty acids (NEFAs), adiponectin, and ghrelin
- A 3-hour one-step hyperinsulinemic euglycemic clamp
- MRS and DEXA scans
- Cortisol clearance rate assessments
- Fat biopsy
Because of the potentially long duration of Visits 1, 2 and 4, the studies can either be divided into two separate admissions upon prior arrangement or can be done all at once with one admission, depending on the subject's wishes and schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: NorditropinGrowth hormone or Placebo 0.1 mg/day self-administrated once a day. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- Age 21 to 65 years
- Body mass index between 25 to 40 kg/m2
- Diagnosis of MBS based on the consensus statement by the International Diabetes Federation i.e., central obesity defined by waist circumference in men of ≥ 94 cm and in women of ≥ 80 cm plus two other components from the following: 1) dyslipidemia (triglyceride levels ≥ 150 mg/dl or on therapy and/or HDL in men of < 40 mg/dl and in women of < 50 mg/dl or on therapy); 2) hypertension (blood pressure ≥ 130/85 mmHg or on therapy and 3) hyperglycemia (fasting plasma glucose ≥ 100 mg/dl or on therapy)
- Stable weight and diet for at least 6 months prior to study entry
Key exclusion criteria (17 listed)
- Inability to comply with study requirements
- Body mass index < 30 kg/m2 and > 40 kg/m2 (patients with body mass index > 40 kg/m2 are excluded because they will not fit into the MRS scanner)
- Untreated hypothyroidism or hyperthyroidism
- Anemia from any cause
- Known diabetes mellitus
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 |
|---|---|---|
| NorditropinAlso: Growth hormone, metabolic syndrome, insulin sensitivityNorditropin 0.1 mg/day self-administered once a day subcutaneously | Drug | 1 |
Primary outcome
Changes in insulin sensitivity, and adipocyte IGF-I and insulin receptor signaling.
Time frame: 24 months
1 secondary outcome
Changes in body composition, cortisol production rates, and muscle and liver intramyocellular content.
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
- Background: PubMed 15248820Yuen K, Wareham N, Frystyk J, Hennings S, Mitchell J, Fryklund L, Dunger D. Short-term low-dose growth hormone administration in subjects with impaired glucose tolerance and the metabolic syndrome: effects on beta-cell function and post-load glucose tolerance. Eur J Endocrinol. 2004 Jul;151(1):39-45. doi: 10.1530/eje.0.1510039.
- American Endocrine SocietyLink provided by the sponsor.
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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.
Kevin C. Yuen, MRCP(UK), MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Norditropin in people with Metabolic Syndrome, 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 8 inclusion and 17 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: withdrawn, as of the sponsor's last update on 20 Feb 2013. 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 was withdrawn before enrolling participants, so there are no results.
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?
Changes in insulin sensitivity, and adipocyte IGF-I and insulin receptor signaling. (time frame: 24 months). 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 NCT00720616, which also lists 1 linked publication.
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 20 Feb 2013.