- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01107808
Calcium, Vitamin D and Metformin to Treat Insulin Resistance in Obese African American Adolescent Females
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.
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- pregnancy
- male
- kidney or liver dysfunction
- unwilling to take pill/medication during the trial interested in becoming pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
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.
|
|
Experimental: Calcium and Vit D
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
|
ergocalciferol (vitamin D2) treatment 50,000 IU orally, weekly for 8 weeks calcium carbonate orally 1200mg daily
Other Names:
|
Experimental: Metformin/ Vit D
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).
|
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)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Low-density lipoprotein LDL
Time Frame: 8 week
|
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.
|
8 week
|
The insulin sensitivity indices (WBISI)
Time Frame: 8 weeks
|
the WBISI will be calculated from glucose and insulin measurements from the OGTT done at the screening and final study visits.
|
8 weeks
|
High density lipoprotein
Time Frame: 8 weeks
|
HDL will be measured by standard laboratory methods through the hospital clinic lab.
The screening and final measurement will be compared for each participant.
|
8 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Stephenie B Wallace, UAB Department of Pediatrics
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Nutrition Disorders
- Hyperinsulinism
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Vitamin D Deficiency
- Insulin Resistance
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Calcium
- Metformin
- Calcium, Dietary
- Ergocalciferols
Other Study ID Numbers
- UAB MHRC SBW
- F090213004 (Other Identifier: UAB IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuNot yet recruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Calcium and Vit D
-
Chinese University of Hong KongCompleted
-
Memorial Medical CenterUnited States Department of DefenseCompletedParkinson DiseaseUnited States
-
Princess Anna Mazowiecka Hospital, Warsaw, PolandMedical University of WarsawCompletedNephrolithiasis | Vitamin D Deficiency | Osteopenia | Drug OverdosePoland
-
University of KansasNational Osteoporosis FoundationCompleted
-
Dow University of Health SciencesUnknownType 2 Diabetes Mellitus | Pulmonary TuberculosisPakistan
-
Rijnstate HospitalCompletedVitamin D Deficiency in Older PersonsNetherlands
-
Changhua Christian HospitalCompleted
-
Children's Memorial Health Institute, PolandNutricia Research FundationCompleted
-
Florence Nightingale Hospital, IstanbulCompletedVitamin D Deficiency | Chemotherapy Effect | PathologyTurkey
-
Tanta UniversityCompleted