Pediatric ObesityPhase 4NCT00667498
Metabolic Effect of Metformin in Obese Insulin Resistant Adolescents With Normal Glucose Tolerance
A Phase 4 study testing Metformin in people with Pediatric Obesity and Insulin Resistance, run by Yale University at 1 site in United States.
Trial summary
The primary objective of this randomized, parallel group, double-blind, placebo-controlled study is to determine whether treatment with metformin enhances insulin sensitivity in a group of ethnically diverse obese insulin-resistant adolescents with normal glucose tolerance. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity, Insulin Resistance, Hyperinsulinemia
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Dec 2007
- Phase
- Phase 4
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Attending weight management clinic at Yale New Haven Hospital
- Good general health, taking no other medication on a chronic basis
- Age 13 to 17 yrs in puberty (girls: breast Tanner stage II to IV, and boys: testes size > 6 ml)
- The presence of insulin resistance, defined by fasting insulin levels greater than 30 µU/ml, and HOMA insulin resistance index > 6
- Normal glucose tolerance based on a 2-hr plasma glucose (<140 mg/dl) after the OGTT.
- All female subjects must have a negative urine pregnancy test during the study visits and must use an effective method of contraception if they are sexually active. Without their parent(s) present, all potential female subjects will be asked about their sexual activity and the specific form of contraception they are using.
Who cannot join
- Baseline creatinine > 1.0 mg/dl
- Hepatic disease with elevated liver function test (ALT or AST) ≥ 2 X the upper limits of normal
- Pregnancy
- Presence of other endocrinopathies; except treated hypothyroidism on stable replacement doses of thyroid hormone
- Presence of cardiac, pulmonary or other significant chronic illness
- Adolescents with psychiatric disorder, claustrophobia or with substance abuse
Show all 10Show fewer
- Recent use (within six months) of anorexic agents
- Presence of anemia (hematocrit < 35)
- Mixed ethnic background (defined as two parents of different ethnicity)
- Adolescents with metal implants (i.e. cardiac pace maker, metal prostheses, bullet remnants)
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Center for Clinical Investigation (YCCI)
New Haven, Connecticut, 06511
About this study
The primary objective of this randomized, parallel group, double-blind, placebo-controlled study is to determine whether treatment with metformin enhances insulin sensitivity in a group of ethnically diverse obese insulin-resistant adolescents with normal glucose tolerance.
Read the detailed description
First Visit
Patients who agree to participate in this research study, will have an initial screening where the subject will be asked about his/her health, a sample of blood will be drawn, the subject will be examined, and an oral glucose tolerance (OGTT) test will be done.
- OGTT: The study takes about four hours and will begin on an "empty stomach." A small I.V. will be placed in a vein in the subject's arm. The I.V. will allow a member of the research team to take small amounts of blood for measuring glucose and other substances that circulate in the blood. About 7 tablespoons of blood will be drawn in total during the OGTT. The I.V. will remain in place all during the study. At the beginning of the study, the subject will be asked to drink about 8 ounces (one cup) of a high sugar cola- or orange-flavored drink.
If the subject meets all the requirements to be in the study and has a normal glucose tolerance test, he/she will be randomized to either the intensely (Euglycemic hyperinsulinemic clamp) or standard studied group and have the following six or seven tests performed: DEXA scan and Tanita, exercise step test, PAT test, MRI (Abdominal scan), MRS (leg scan), and Euglycemic hyperinsulinemic clamp (intensely studied group only). All of the tests are described below. Females will have a urine pregnancy test before each of these tests. If positive, the subject will not be allowed to participate/continue with the study.
- DEXA / Tanita: The DEXA scan will measure how much muscle and fat is in the subject's body and how dense the subject's bones are using an x-ray technique. Directly after the DEXA Scan, the subject's percentage of body fat will be measured using a Tanita scale.
- Exercise Step Test: The subject will be asked to step up and down two steps 20 times at their own pace. We will measure the subject's heart rate directly before and for three minutes after this exercise. After a ten minute break, the test will be repeated.
- Peripheral Arterial Tonometry (PAT): This test will allow us to evaluate the response of the small blood vessels in the subject's arm to changes in nerve signals to them. During this test, we will put a probe (similar to a tight-fitting glove) on one finger of each of the subject's hands and take some measurements for about five minutes. The probes contain latex, so this test will not be performed on subjects who are allergic to latex. Following these measurements, we will block blood flow to one of the hands for five minutes by putting a blood pressure cuff on one of the arms and inflating the cuff. After the pressure in the cuff is released, we will take more measurements for about five minutes.
- MRI (Belly Scan): Magnetic Resonance Imaging (MRI) will be used to take pictures of the subject's belly. These pictures will allow us to calculate how much fat the subject has just below the skin and how much fat is deeper inside the belly. We will also be able to estimate the percentage of fat in the subject's liver.
- MRS (Leg scan): We will measure how much fat is in the subject's calf muscle using magnetic resonance spectroscopy (MRS).
- Insulin, Glucose and Glycerol Infusion Study (Euglycemic hyperinsulinemic clamp): A small I.V. will be placed into a vein in each arm. One I.V. will be used to take out small amounts of blood for measuring the blood sugar and other substances that circulate in the blood. The other I.V. will be used to infuse insulin, glucose, and glycerol into the subject's blood. Insulin is a hormone that helps bring blood sugar into the cells. Glycerol is a component of fat that is normally present in a person's body.
This infusion will not affect the subject's blood sugar in a harmful manner. It will allow us to follow the release of glucose from the liver and glycerol from fat tissue.
The subject's blood sugar will be checked closely during the study by taking blood samples from the second I.V. Readings of the blood sugar on each sample will be made at the bedside. If the blood sugar starts to fall, it can be fixed right away. At the end of another three hours, the infusion will be stopped and the subject will eat a meal that will be provided for him/her. The infusion of glucose will be reduced while the subject is eating until the subject's blood sugar is stable. This test takes about 6 hours. The total amount of blood drawn during this test will be less than 8 tablespoons or about half a cup.
Indirect calorimetry is a way to measure how much sugar and fat a person is burning when we give insulin. Testing how much fat and sugar a subject burns is an important part of the insulin, glucose, and glycerol infusion study. Therefore we will ask the subject to wear a plastic hood (like an astronaut space helmet) before starting the infusion of insulin and at two other times during the study.
Taking Metformin or Placebo
Once the subject has completed the six (standard studied group) or seven (intensely studied group only) tests described above, as well as two urine tests for protein, he/she will be randomized to either:
- Take Metformin; or
- Take a placebo pill
The subject will begin by taking one pill (either Metformin or placebo) every day, just before supper. The dose will be slowly increased as follows:
Week 1: Before breakfast = 0 and Before supper = 1 (500mg); Week 2: Before breakfast = 1 (500mg) and Before supper = 1 (500mg); Week 3-14: Before breakfast = 1 (500mg) and Before supper = 2 (500mg)
The subject will be taking the pills for 3 1/2 months, during which time we will ask that he/she keep a diary of any complaints, problems, or symptoms. Neither the subject, the subject's doctor, nor any of the members of the research team will find out which pill the subject was taking until the end of the study.
Monthly Follow-up
Subjects will be asked to come back every month for a physical exam. We will measure their height, weight, and blood pressure each time. A urine pregnancy test will be done on all female participants at every visit. At the subject's first follow up visit we will draw a small amount of blood and run tests to make sure the subject is healthy. We will ask the subject and his/her parent about any symptoms that the subject has had, any pills that he/she might have missed taking, and the use of other medications. We will measure the subject's vitamin B12 level on his/her third follow up visit.
End of Study
About three months after the subject begins taking the Metformin or placebo pills, he/she will repeat the tests described above (oral glucose tolerance test, DEXA and Tanita, exercise step test, PAT test, MRI, and MRS). In the sub-group of participants who had the glucose, insulin, and glycerol infusion test, this will also be repeated at the end of the study.
Open Label Phase (Taking Metformin)
After the tests described above are completed, all participants (even if they had been assigned a placebo pill) will be given the choice of taking Metformin for the next six months. If the subject does choose to continue, we will continue to monitor him/her monthly, as described in the section above on monthly follow-up. At the end of the additional six months, we will repeat all the tests that the subject had at the beginning of the study. For the intensely studied group, this includes the insulin, glucose and glycerol infusion.
- Conditions
- Pediatric Obesity, Insulin Resistance, Hyperinsulinemia
- Being tested
- Metformin, Placebo
- Keywords
- Pediatric Obesity, Insulin Resistance, Hyperinsulinemia, Metformin, Glucose Tolerance, Microalbuminuria, Adolescents, Visceral Fat
- Medical subject headings
- Pediatric Obesity, Insulin Resistance, Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage, Glucophage XR, Glumetza, Fortamet, Riomet
The subject will receive either metformin or placebo drug, given as 500mg tablets (or corresponding placebos) necessary to increase the dose incrementally over a three week period.
The time it takes to incrementally increase the dose to the desired dose of 500mg in am and 1000mg in pm will count as intervention time. Both the metformin and placebo group will also be given a multivitamin with vitamin B12 to avoid potential anemia.
PlaceboDrug
The subject will receive either metformin or placebo drug, given as 500mg tablets (or corresponding placebos) necessary to increase the dose incrementally over a three week period.
The time it takes to incrementally increase the dose to the desired dose of 500mg in am and 1000mg in pm will count as intervention time. Both the metformin and placebo group will also be given a multivitamin with vitamin B12 to avoid potential anemia.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Metformin |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of insulin sensitivity: Whole Body Insulin Sensitivity Index (WBISI), Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), and Euglycemic hyperinsulinemic clamp
Measured: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Secondary outcomes (19)
Body mass index (BMI)
Measured: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Waist to hip circumference ratio
Measured: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Muscle lipid content
Measured: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Total body fat
Measured: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Abdominal fat mass
Measured: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Hepatic fat fraction
Measured: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Hepatic iron concentration
Measured: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Plasma ghrelin levels
Measured: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Adiponectin levels
Measured: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Leptin levels
Measured: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Blood pressure
Measured: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Lipid profile
Measured: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Microalbuminuria
Measured: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Inflammatory markers (Plasminogen activator inhibitor-1 (PAI-1), C-reactive protein (CRP), homocysteine, tumor necrosis factor (TNF)-α, Interleukin (IL)-6)
Measured: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Self-paced step test (Heart rate recovery after exercise)
Measured: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Peripheral Arterial Tonometry (PAT)
Measured: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Females only: Markers of polycystic ovarian syndrome (PCOS) - Adrenal androgens (17 Hydroxyprogesterone, Dehydroepiandrosterone), sex hormone binding globulin (SHBG), free testosterone, LH/FSH ratio
Measured: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Females only: Menstrual pattern
Measured: Throughout study
Ethnic stratification (Hispanic, African American or Caucasian)
Measured: Baseline (month 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startMar 2004
- Primary completionDec 2007
- Study completionDec 2007
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 Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Yale 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Tania S Burgert, MD, Principal investigator, Yale University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667498
- Sponsor's protocol ID
- 0311026134
- Status last verified
- Feb 2009
- First submitted
- 24 Apr 2008
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Burgert TS, Duran EJ, Goldberg-Gell R, Dziura J, Yeckel CW, Katz S, Tamborlane WV, Caprio S. Short-term metabolic and cardiovascular effects of metformin in markedly obese adolescents with normal glucose tolerance. Pediatr Diabetes. 2008 Dec;9(6):567-76. doi: 10.1111/j.1399-5448.2008.00434.x. Epub 2008 Aug 27.
PubMed 18761646
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effect of Metformin in Obese Insulin Resistant Adolescents With Normal Glucose Tolerance
- ClinicalTrials.gov ID
- NCT00667498
- Acronym / sponsor ID
- 0311026134
- Conditions
- Pediatric Obesity, Insulin Resistance, Hyperinsulinemia
- Keywords
- Pediatric Obesity, Insulin Resistance, Hyperinsulinemia, Metformin, Glucose Tolerance, Microalbuminuria, Adolescents, Visceral Fat
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Mar 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 28 Apr 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.
The primary objective of this randomized, parallel group, double-blind, placebo-controlled study is to determine whether treatment with metformin enhances insulin sensitivity in a group of ethnically diverse obese insulin-resistant adolescents with normal glucose tolerance.
Detailed description
First Visit
Patients who agree to participate in this research study, will have an initial screening where the subject will be asked about his/her health, a sample of blood will be drawn, the subject will be examined, and an oral glucose tolerance (OGTT) test will be done.
- OGTT: The study takes about four hours and will begin on an "empty stomach." A small I.V. will be placed in a vein in the subject's arm. The I.V. will allow a member of the research team to take small amounts of blood for measuring glucose and other substances that circulate in the blood. About 7 tablespoons of blood will be drawn in total during the OGTT. The I.V. will remain in place all during the study. At the beginning of the study, the subject will be asked to drink about 8 ounces (one cup) of a high sugar cola- or orange-flavored drink.
If the subject meets all the requirements to be in the study and has a normal glucose tolerance test, he/she will be randomized to either the intensely (Euglycemic hyperinsulinemic clamp) or standard studied group and have the following six or seven tests performed: DEXA scan and Tanita, exercise step test, PAT test, MRI (Abdominal scan), MRS (leg scan), and Euglycemic hyperinsulinemic clamp (intensely studied group only). All of the tests are described below. Females will have a urine pregnancy test before each of these tests. If positive, the subject will not be allowed to participate/continue with the study.
- DEXA / Tanita: The DEXA scan will measure how much muscle and fat is in the subject's body and how dense the subject's bones are using an x-ray technique. Directly after the DEXA Scan, the subject's percentage of body fat will be measured using a Tanita scale.
- Exercise Step Test: The subject will be asked to step up and down two steps 20 times at their own pace. We will measure the subject's heart rate directly before and for three minutes after this exercise. After a ten minute break, the test will be repeated.
- Peripheral Arterial Tonometry (PAT): This test will allow us to evaluate the response of the small blood vessels in the subject's arm to changes in nerve signals to them. During this test, we will put a probe (similar to a tight-fitting glove) on one finger of each of the subject's hands and take some measurements for about five minutes. The probes contain latex, so this test will not be performed on subjects who are allergic to latex. Following these measurements, we will block blood flow to one of the hands for five minutes by putting a blood pressure cuff on one of the arms and inflating the cuff. After the pressure in the cuff is released, we will take more measurements for about five minutes.
- MRI (Belly Scan): Magnetic Resonance Imaging (MRI) will be used to take pictures of the subject's belly. These pictures will allow us to calculate how much fat the subject has just below the skin and how much fat is deeper inside the belly. We will also be able to estimate the percentage of fat in the subject's liver.
- MRS (Leg scan): We will measure how much fat is in the subject's calf muscle using magnetic resonance spectroscopy (MRS).
- Insulin, Glucose and Glycerol Infusion Study (Euglycemic hyperinsulinemic clamp): A small I.V. will be placed into a vein in each arm. One I.V. will be used to take out small amounts of blood for measuring the blood sugar and other substances that circulate in the blood. The other I.V. will be used to infuse insulin, glucose, and glycerol into the subject's blood. Insulin is a hormone that helps bring blood sugar into the cells. Glycerol is a component of fat that is normally present in a person's body.
This infusion will not affect the subject's blood sugar in a harmful manner. It will allow us to follow the release of glucose from the liver and glycerol from fat tissue.
The subject's blood sugar will be checked closely during the study by taking blood samples from the second I.V. Readings of the blood sugar on each sample will be made at the bedside. If the blood sugar starts to fall, it can be fixed right away. At the end of another three hours, the infusion will be stopped and the subject will eat a meal that will be provided for him/her. The infusion of glucose will be reduced while the subject is eating until the subject's blood sugar is stable. This test takes about 6 hours. The total amount of blood drawn during this test will be less than 8 tablespoons or about half a cup.
Indirect calorimetry is a way to measure how much sugar and fat a person is burning when we give insulin. Testing how much fat and sugar a subject burns is an important part of the insulin, glucose, and glycerol infusion study. Therefore we will ask the subject to wear a plastic hood (like an astronaut space helmet) before starting the infusion of insulin and at two other times during the study.
Taking Metformin or Placebo
Once the subject has completed the six (standard studied group) or seven (intensely studied group only) tests described above, as well as two urine tests for protein, he/she will be randomized to either:
- Take Metformin; or
- Take a placebo pill
The subject will begin by taking one pill (either Metformin or placebo) every day, just before supper. The dose will be slowly increased as follows:
Week 1: Before breakfast = 0 and Before supper = 1 (500mg); Week 2: Before breakfast = 1 (500mg) and Before supper = 1 (500mg); Week 3-14: Before breakfast = 1 (500mg) and Before supper = 2 (500mg)
The subject will be taking the pills for 3 1/2 months, during which time we will ask that he/she keep a diary of any complaints, problems, or symptoms. Neither the subject, the subject's doctor, nor any of the members of the research team will find out which pill the subject was taking until the end of the study.
Monthly Follow-up
Subjects will be asked to come back every month for a physical exam. We will measure their height, weight, and blood pressure each time. A urine pregnancy test will be done on all female participants at every visit. At the subject's first follow up visit we will draw a small amount of blood and run tests to make sure the subject is healthy. We will ask the subject and his/her parent about any symptoms that the subject has had, any pills that he/she might have missed taking, and the use of other medications. We will measure the subject's vitamin B12 level on his/her third follow up visit.
End of Study
About three months after the subject begins taking the Metformin or placebo pills, he/she will repeat the tests described above (oral glucose tolerance test, DEXA and Tanita, exercise step test, PAT test, MRI, and MRS). In the sub-group of participants who had the glucose, insulin, and glycerol infusion test, this will also be repeated at the end of the study.
Open Label Phase (Taking Metformin)
After the tests described above are completed, all participants (even if they had been assigned a placebo pill) will be given the choice of taking Metformin for the next six months. If the subject does choose to continue, we will continue to monitor him/her monthly, as described in the section above on monthly follow-up. At the end of the additional six months, we will repeat all the tests that the subject had at the beginning of the study. For the intensely studied group, this includes the insulin, glucose and glycerol infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Metformin |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Attending weight management clinic at Yale New Haven Hospital
- Good general health, taking no other medication on a chronic basis
- Age 13 to 17 yrs in puberty (girls: breast Tanner stage II to IV, and boys: testes size > 6 ml)
- The presence of insulin resistance, defined by fasting insulin levels greater than 30 µU/ml, and HOMA insulin resistance index > 6
- Normal glucose tolerance based on a 2-hr plasma glucose (<140 mg/dl) after the OGTT.
Key exclusion criteria (10 listed)
- Baseline creatinine > 1.0 mg/dl
- Hepatic disease with elevated liver function test (ALT or AST) ≥ 2 X the upper limits of normal
- Pregnancy
- Presence of other endocrinopathies; except treated hypothyroidism on stable replacement doses of thyroid hormone
- Presence of cardiac, pulmonary or other significant chronic illness
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 |
|---|---|---|
| MetforminAlso: Glucophage, Glucophage XR, Glumetza, Fortamet, RiometThe subject will receive either metformin or placebo drug, given as 500mg tablets (or corresponding placebos) necessary to increase the dose incrementally over a three week period. The time it takes to incrementally increase the dose to the desired dose of 500mg in am and 1000mg in pm will count as intervention time. Both the metformin and placebo group will also be given a multivitamin with vitamin B12 to avoid potential anemia. | Drug | 1 |
| PlaceboThe subject will receive either metformin or placebo drug, given as 500mg tablets (or corresponding placebos) necessary to increase the dose incrementally over a three week period. The time it takes to incrementally increase the dose to the desired dose of 500mg in am and 1000mg in pm will count as intervention time. Both the metformin and placebo group will also be given a multivitamin with vitamin B12 to avoid potential anemia. | Drug | 2 |
Primary outcome
Assessment of insulin sensitivity: Whole Body Insulin Sensitivity Index (WBISI), Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), and Euglycemic hyperinsulinemic clamp
Time frame: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
19 secondary outcomes
Body mass index (BMI)
Time frame: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Waist to hip circumference ratio
Time frame: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Muscle lipid content
Time frame: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Total body fat
Time frame: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Abdominal fat mass
Time frame: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Hepatic fat fraction
Time frame: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Hepatic iron concentration
Time frame: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Plasma ghrelin levels
Time frame: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Adiponectin levels
Time frame: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Leptin levels
Time frame: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Blood pressure
Time frame: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Lipid profile
Time frame: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Microalbuminuria
Time frame: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Inflammatory markers (Plasminogen activator inhibitor-1 (PAI-1), C-reactive protein (CRP), homocysteine, tumor necrosis factor (TNF)-α, Interleukin (IL)-6)
Time frame: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Self-paced step test (Heart rate recovery after exercise)
Time frame: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Peripheral Arterial Tonometry (PAT)
Time frame: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Females only: Markers of polycystic ovarian syndrome (PCOS) - Adrenal androgens (17 Hydroxyprogesterone, Dehydroepiandrosterone), sex hormone binding globulin (SHBG), free testosterone, LH/FSH ratio
Time frame: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
Females only: Menstrual pattern
Time frame: Throughout study
Ethnic stratification (Hispanic, African American or Caucasian)
Time frame: Baseline (month 0)
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 18 Feb 2009.
- Results publication: PubMed 18761646Burgert TS, Duran EJ, Goldberg-Gell R, Dziura J, Yeckel CW, Katz S, Tamborlane WV, Caprio S. Short-term metabolic and cardiovascular effects of metformin in markedly obese adolescents with normal glucose tolerance. Pediatr Diabetes. 2008 Dec;9(6):567-76. doi: 10.1111/j.1399-5448.2008.00434.x. Epub 2008 Aug 27.
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Obesity, Overweight
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.
Tania S Burgert, MD principal investigator
Yale University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin in people with Pediatric Obesity and Insulin Resistance, run by Yale 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 6 inclusion and 10 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 18 Feb 2009. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Assessment of insulin sensitivity: Whole Body Insulin Sensitivity Index (WBISI), Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), and Euglycemic hyperinsulinemic clamp (time frame: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).). 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 NCT00667498, 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 18 Feb 2009.