Insulin ResistanceNCT01107808
Calcium, Vitamin D and Metformin to Treat Insulin Resistance in Obese African American Adolescent Females
A study testing Calcium and Vit D and Metformin, Vit D and Calcium in people with Insulin Resistance and Insulin Sensitivity, run by University of Alabama at Birmingham.
Trial summary
This is a feasibility study to examine the treatment with Metformin, vitamin D with calcium supplement for insulin resistance in obese, black, female teens. The association of low vitamin D levels and decreased insulin sensitivity has been established. Read more about this study
- Who is it for?
- Ages 14 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Insulin Sensitivity, Obesity
- What is being tested?
- Calcium and Vit D and Metformin, Vit D and Calcium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Mar 2011
- 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 14 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 14-19 years old
- female
- african american
- obese
- risk of insulin resistance (physical exam or family history of diabetes
- willing to be randomized to a arm that would take medication
Who cannot join
- pregnancy
- male
- kidney or liver dysfunction
- unwilling to take pill/medication during the trial interested in becoming pregnant
About this study
Official title: Calcium, Vitamin D and Metformin to Treat Insulin Resistance in Obese African American Adolescent Females.
This is a feasibility study to examine the treatment with Metformin, vitamin D with calcium supplement for insulin resistance in obese, black, female teens. The association of low vitamin D levels and decreased insulin sensitivity has been established. Thus, the specific aims of this study are:
Specific aim 1: To examine the effect of an 8-week treatment with vitamin D and calcium supplementations on diabetes-related risk factors in obese, black, female teens.
Read more
Hypothesis 1a: In obese, black, female teens with both insulin resistance and vitamin D deficiency, treatment with vitamin D and calcium supplementation will significantly improve measures of insulin resistance and sensitivity (as determined by the homeostatic model assessment for insulin resistance and whole body insulin sensitivity index measures) when compared to controls not receiving vitamin D and calcium.
Hypothesis 1b: In obese, black teen females with both insulin resistance and vitamin D deficiency, treatment with vitamin D and calcium supplementation will significantly improve measures of cardiovascular disease (decreased BMI and improved triglycerides and LDL) when compared to controls not receiving vitamin D and calcium.
Specific aim 2: To determine if the addition of Metformin to the 8-week treatment with vitamin D and calcium supplementations improves diabetes-related risk factors in obese, black, female teens.
Hypothesis 2a: In obese, black, female teens with both insulin resistance and vitamin D deficiency, treatment with Metformin, vitamin D, and calcium supplementation will significantly improve measures of insulin resistance and sensitivity (as determined by the homeostatic model assessment for insulin resistance and whole body insulin sensitivity index measures) when compared to standard of care or treatment with vitamin D with calcium supplementation alone while controlling for dietary intake of vitamin D and calcium.
Hypothesis 2b: In obese, black, female teens with both insulin resistance and vitamin D deficiency, treatment with Metformin, vitamin D, and calcium supplementation will significantly improve measures of cardiovascular disease risk (as determined by the decreased BMI, improved triglycerides and LDL) when compared to standard of care or treatment with vitamin D with calcium supplementation alone while controlling for dietary intake of vitamin D and calcium.
Read the detailed description
The increasing rate of obesity in youth has reached epidemic proportion in the United States. African Americans share an overwhelming burden of this disorder and its complications.1 Vitamin D deficiency is prevalent in black girls and women2 and is associated with insulin resistance in populations at risk for diabetes.3 The use of Metformin, an oral diabetic agent, to halt the progression to diabetes in individuals at risk has been studied, but not in a population with concurrent vitamin D deficiency. In this proposal, we hypothesize that treatment with vitamin D with calcium supplement along with Metformin together will improve insulin resistance in obese, black teen girls. We will investigate this hypothesis in two specific aims to: 1) examine the effect of treatment of Vitamin D deficiency on insulin resistance in mature black teen girls, 2) to determine if there is any additional benefit of Metformin with treatment for Vitamin D deficiency to improve insulin resistance in this group. We propose to accomplish these aims through a clinical trial in obese black teen girls who have reached developmental maturity (approximately 15-18 years old) with vitamin D deficiency. Eligible participants will be randomized to one of three groups: standard of care, treatment with vitamin D/calcium supplement, and treatment with Vitamin D/Calcium Supplement and Metformin. We will enroll 30 obese adolescent subjects, (10 participants per group) into this 2-month study. The following measurements will be performed at baseline and 2 month follow-up: a) 25-hydroxy-vitamin D, b) Oral glucose tolerance tests to calculate homeostatic model assessment for insulin resistance (HOMA IR), and 4 to determine insulin resistance and total body insulin sensitivity index (TBISI) to determine insulin sensitivity,5 c) body mass index calculations, and c) lipid panel to include triglyceride, HDL-C, and LDL-C measurements. We will control for the effect of nutritional counseling on vitamin D and calcium intake will be controlled. Our outcome measures will include improvement in insulin resistance and decreased body mass index for our participants treated with vitamin D, calcium supplementation and Metformin. Validation of our hypothesis will show that Metformin along with vitamin D treatment and calcium supplementation is a novel treatment combination to improve insulin resistance, the health of an at-risk adolescent population.
- Conditions
- Insulin Resistance, Insulin Sensitivity, Obesity, Vitamin D Deficiency
- Being tested
- Calcium and Vit D, Metformin, Vit D and Calcium
- Keywords
- Adolescents, African American, Female
- Medical subject headings
- Insulin Resistance, Obesity, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium and Vit DDrug
Also called Vitamin D2 =ergocalciferol
ergocalciferol (vitamin D2) treatment 50,000 IU orally, weekly for 8 weeks calcium carbonate orally 1200mg daily
Metformin, Vit D and CalciumDrug
Also called Gluophage
ergocalciferol (vitamin D2)50,000 IU orally weekly for 8 weeks calcium carbonate orally 1200mg daily Metformin ER 1000mg daily with dinner for 7 days and then increased to a final dose of 2000mg orally, daily for the remainder of the study (7 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The adolescents randomized to Standard of care group will receive the medical and behavioral counseling regarding their obesity as a patient of the Children's Center for Weight Management (CCWM). They will not receive any pharmacological treatment for their vitamin D deficiency or insulin resistance. Calcium and vitamin D dietary intake will be determined using a specific food frequency questionnaire at each study visit for all groups. This will be used to determine effect of nutrition counseling. |
| Calcium and Vit D | Experimental | The participants in the vitamin D/calcium group will receive standard of care through the CCWM along with the addition of treatment with ergocalciferol (vitamin D2) and calcium carbonate for their vitamin D deficiency. The vitamin D treatment will be 50,000 IU orally weekly for 8 weeks. This treatment regimen for vitamin D deficiency has been found to be safe to children and adolescents. 32 33The dose of calcium supplementation will be calcium carbonate orally 1200mg daily. This is the daily recommended intake of calcium for adolescents Receives: Drug: Calcium and Vit D |
| Metformin/ Vit D | Experimental | The participants randomized into the vitamin D/calcium/Metformin treatment group will receive standard of care through the CCWM in addition to treatment for their Vitamin D deficiency with the same doses of ergocalciferol (vitamin D2) and calcium carbonate as previously outlined. Additionally, these participants will receive Metformin ER to treat insulin resistance. The Metformin ER will be started at 1000mg daily with dinner for 7 days and then increased to a final dose of 2000mg orally, daily for the remainder of the study (7 weeks). Receives: Drug: Metformin, Vit D and Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The insulin sensitivity indices (HOMA IR)
the HOMA IR will be calculated from glucose and insulin measurements from the OGTT done at the screening and final study visits.
Measured: 8 weeks
Secondary outcomes (3)
Low-density lipoprotein LDL
LDL-C will be measured by standard laboratory methods through the hospital clinic lab.The screening and final measurement will be compared for each participant.
Measured: 8 week
The insulin sensitivity indices (WBISI)
the WBISI will be calculated from glucose and insulin measurements from the OGTT done at the screening and final study visits.
Measured: 8 weeks
High density lipoprotein
HDL will be measured by standard laboratory methods through the hospital clinic lab. The screening and final measurement will be compared for each participant.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startJun 2009
- Primary completionSep 2010 (estimated)
- Study completionMar 2011 (estimated)
Why it stopped: Poor recruitment to the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Investigators
- Stephenie B Wallace, Principal investigator, UAB Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107808
- Sponsor's protocol ID
- UAB MHRC SBW
- Other IDs
- F090213004
- Status last verified
- Mar 2011
- First submitted
- 1 Apr 2010
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium, Vitamin D and Metformin to Treat Insulin Resistance in Obese African American Adolescent Females.
- ClinicalTrials.gov ID
- NCT01107808
- Acronym / sponsor ID
- UAB MHRC SBW
- Conditions
- Insulin Resistance, Insulin Sensitivity, Obesity, Vitamin D Deficiency
- Keywords
- Adolescents, African American, Female
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Poor recruitment to the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 21 Apr 2010 (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.
This is a feasibility study to examine the treatment with Metformin, vitamin D with calcium supplement for insulin resistance in obese, black, female teens. The association of low vitamin D levels and decreased insulin sensitivity has been established. Thus, the specific aims of this study are:
Specific aim 1: To examine the effect of an 8-week treatment with vitamin D and calcium supplementations on diabetes-related risk factors in obese, black, female teens.
Hypothesis 1a: In obese, black, female teens with both insulin resistance and vitamin D deficiency, treatment with vitamin D and calcium supplementation will significantly improve measures of insulin resistance and sensitivity (as determined by the homeostatic model assessment for insulin resistance and whole body insulin sensitivity index measures) when compared to controls not receiving vitamin D and calcium.
Hypothesis 1b: In obese, black teen females with both insulin resistance and vitamin D deficiency, treatment with vitamin D and calcium supplementation will significantly improve measures of cardiovascular disease (decreased BMI and improved triglycerides and LDL) when compared to controls not receiving vitamin D and calcium.
Specific aim 2: To determine if the addition of Metformin to the 8-week treatment with vitamin D and calcium supplementations improves diabetes-related risk factors in obese, black, female teens.
Hypothesis 2a: In obese, black, female teens with both insulin resistance and vitamin D deficiency, treatment with Metformin, vitamin D, and calcium supplementation will significantly improve measures of insulin resistance and sensitivity (as determined by the homeostatic model assessment for insulin resistance and whole body insulin sensitivity index measures) when compared to standard of care or treatment with vitamin D with calcium supplementation alone while controlling for dietary intake of vitamin D and calcium.
Hypothesis 2b: In obese, black, female teens with both insulin resistance and vitamin D deficiency, treatment with Metformin, vitamin D, and calcium supplementation will significantly improve measures of cardiovascular disease risk (as determined by the decreased BMI, improved triglycerides and LDL) when compared to standard of care or treatment with vitamin D with calcium supplementation alone while controlling for dietary intake of vitamin D and calcium.
Detailed description
The increasing rate of obesity in youth has reached epidemic proportion in the United States. African Americans share an overwhelming burden of this disorder and its complications.1 Vitamin D deficiency is prevalent in black girls and women2 and is associated with insulin resistance in populations at risk for diabetes.3 The use of Metformin, an oral diabetic agent, to halt the progression to diabetes in individuals at risk has been studied, but not in a population with concurrent vitamin D deficiency. In this proposal, we hypothesize that treatment with vitamin D with calcium supplement along with Metformin together will improve insulin resistance in obese, black teen girls. We will investigate this hypothesis in two specific aims to: 1) examine the effect of treatment of Vitamin D deficiency on insulin resistance in mature black teen girls, 2) to determine if there is any additional benefit of Metformin with treatment for Vitamin D deficiency to improve insulin resistance in this group. We propose to accomplish these aims through a clinical trial in obese black teen girls who have reached developmental maturity (approximately 15-18 years old) with vitamin D deficiency. Eligible participants will be randomized to one of three groups: standard of care, treatment with vitamin D/calcium supplement, and treatment with Vitamin D/Calcium Supplement and Metformin. We will enroll 30 obese adolescent subjects, (10 participants per group) into this 2-month study. The following measurements will be performed at baseline and 2 month follow-up: a) 25-hydroxy-vitamin D, b) Oral glucose tolerance tests to calculate homeostatic model assessment for insulin resistance (HOMA IR), and 4 to determine insulin resistance and total body insulin sensitivity index (TBISI) to determine insulin sensitivity,5 c) body mass index calculations, and c) lipid panel to include triglyceride, HDL-C, and LDL-C measurements. We will control for the effect of nutritional counseling on vitamin D and calcium intake will be controlled. Our outcome measures will include improvement in insulin resistance and decreased body mass index for our participants treated with vitamin D, calcium supplementation and Metformin. Validation of our hypothesis will show that Metformin along with vitamin D treatment and calcium supplementation is a novel treatment combination to improve insulin resistance, the health of an at-risk adolescent population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The adolescents randomized to Standard of care group will receive the medical and behavioral counseling regarding their obesity as a patient of the Children's Center for Weight Management (CCWM). They will not receive any pharmacological treatment for their vitamin D deficiency or insulin resistance. Calcium and vitamin D dietary intake will be determined using a specific food frequency questionnaire at each study visit for all groups. This will be used to determine effect of nutrition counseling. |
| Calcium and Vit D | Experimental | Drug: Calcium and Vit DThe participants in the vitamin D/calcium group will receive standard of care through the CCWM along with the addition of treatment with ergocalciferol (vitamin D2) and calcium carbonate for their vitamin D deficiency. The vitamin D treatment will be 50,000 IU orally weekly for 8 weeks. This treatment regimen for vitamin D deficiency has been found to be safe to children and adolescents. 32 33The dose of calcium supplementation will be calcium carbonate orally 1200mg daily. This is the daily recommended intake of calcium for adolescents |
| Metformin/ Vit D | Experimental | Drug: Metformin, Vit D and CalciumThe participants randomized into the vitamin D/calcium/Metformin treatment group will receive standard of care through the CCWM in addition to treatment for their Vitamin D deficiency with the same doses of ergocalciferol (vitamin D2) and calcium carbonate as previously outlined. Additionally, these participants will receive Metformin ER to treat insulin resistance. The Metformin ER will be started at 1000mg daily with dinner for 7 days and then increased to a final dose of 2000mg orally, daily for the remainder of the study (7 weeks). |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 14-19 years old
- female
- african american
- obese
- risk of insulin resistance (physical exam or family history of diabetes
Key exclusion criteria (4 listed)
- pregnancy
- male
- kidney or liver dysfunction
- unwilling to take pill/medication during the trial interested in becoming pregnant
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 |
|---|---|---|
| Calcium and Vit DAlso: Vitamin D2 =ergocalciferolergocalciferol (vitamin D2) treatment 50,000 IU orally, weekly for 8 weeks calcium carbonate orally 1200mg daily | Drug | Calcium and Vit D |
| Metformin, Vit D and CalciumAlso: Gluophageergocalciferol (vitamin D2)50,000 IU orally weekly for 8 weeks calcium carbonate orally 1200mg daily Metformin ER 1000mg daily with dinner for 7 days and then increased to a final dose of 2000mg orally, daily for the remainder of the study (7 weeks) | Drug | Metformin/ Vit D |
Primary outcome
The insulin sensitivity indices (HOMA IR)
Time frame: 8 weeks
the HOMA IR will be calculated from glucose and insulin measurements from the OGTT done at the screening and final study visits.
3 secondary outcomes
Low-density lipoprotein LDL
Time frame: 8 week
The insulin sensitivity indices (WBISI)
Time frame: 8 weeks
High density lipoprotein
Time frame: 8 weeks
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 10 Mar 2015.
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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.
Stephenie B Wallace principal investigator
UAB Department of Pediatrics
Questions about this trial
What is this clinical trial studying?
A study testing Calcium and Vit D and Metformin, Vit D and Calcium in people with Insulin Resistance and Insulin Sensitivity, run by University of Alabama at Birmingham.
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 4 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 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The insulin sensitivity indices (HOMA IR) (time frame: 8 weeks). 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 10 Mar 2015.