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Diabetes Mellitus, Type 2NCT00289354

Efficacy and Safety Study of Chromium Picolinate + Biotin on Glucose and Cholesterol Control in T2DM

A study testing Chromium Picolinate (600 mcg Cr) + biotin (2 mg) in people with Diabetes Mellitus, Type 2, run by Nutrition 21, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the effect of the combination of chromium picolinate (600 μg Cr) + biotin (2 mg) versus placebo on glycosylated hemoglobin (HbA1c), lipid profiles (Total-C, HDL-C, LDL-C, TGs, TG/HDL ratio, etc), and pharmacoeconomic outcomes as measured at the Baseline Visit and 90 days later at the Final Visit. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Chromium Picolinate (600 mcg Cr) + biotin (2 mg)
How many people
600 participants
Where
No sites listed yet
Study dates
Mar 2003to Nov 2005
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of type 2 diabetes > 12 months.
  • Male and female between the ages of 18 and 70 years, inclusive.
  • HbA1c > 7.0%.
  • Subject must be receiving an anti-hyperglycemic medication. Medication dosage must be stable for at least 60 days prior to entering trial. Insulin usage must be for rescue purposes only. Rescue insulin use may not be more than once per week.
  • Subjects with a body mass index (BMI) >/= 25 and < 35.
  • Subject must be ambulatory.
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  • Willing to perform self-administered blood glucose monitoring.
  • Willing to complete all study related requirements.
  • Subject will provide written consent to participate in the trial and this consent must be given voluntarily.

Who cannot join

  • Diagnosis of type 1 diabetes.
  • Hypoglycemic event requiring EMS intervention within 12 months.
  • Diabetic Ketoacidosis (DKA) within 12 months.
  • Subjects taking any supplement containing chromium picolinate within the last 90 days prior to enrollment.
  • Subjects taking a supplement or multivitamin containing any other form of chromium > 120 mcg/daily within the last 30 days prior to enrollment.
  • Creatinine > 2.0 x ULN; AST or ALT > 2.0 x ULN; Total Bilirubin > 1.5 x ULN
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  • COPD, CHF, Angina, HTN, MI, or any other CVD requiring hospitalization within 12 months.
  • History of cerebrovascular accident (CVA), pulmonary embolism (PE), or an unresolved deep vein thrombosis (DVT).
  • History of CABG, PTCA, or any other reperfusion therapy within 12 months.
  • Seated systolic BP > 160 mmHg.
  • Morbid obesity.
  • Any psychiatric or mental health issue that would prevent the subject from completing the study. (e.g. Severe depression, schizophrenia, high suicide risk, bi-polar disorder, dementia, substance abuse, etc,)
  • History of any serious immunosuppressive disorder or current immunosuppressive therapy.
  • Female subjects who are pregnant or nursing, or are planning on becoming pregnant during the study.
  • Any illness or complication factor that, in the opinion of the investigator, would jeopardize the subject's health or well being by participating in the study or would interfere with the subject successfully completing the study.
  • Current diagnosis of any uncontrolled metabolic disease that would affect carbohydrate or glucose metabolism other than type 2 diabetes. (e.g. hyper or hypothyroidism). (NOTE: Subject's condition must be stable for > 12 months with no medication changes within the last 12 months preceding enrollment. Subject's TSH must be within range of normality at the time of enrollment to qualify).
  • Current participation in any other clinical research trial for any product or device, or participation in said clinical trials within 30 days prior to enrollment.

About this study

Official title: Randomized, Double Blinded, Placebo Controlled, Study to Evaluate Improvements in Glycemic Control, Lipid Levels, Quality of Life and Healthcare Costs After Daily Administration of Chromium Picolinate and Biotin in Patients With T2DM

To evaluate the effect of the combination of chromium picolinate (600 μg Cr) + biotin (2 mg) versus placebo on glycosylated hemoglobin (HbA1c), lipid profiles (Total-C, HDL-C, LDL-C, TGs, TG/HDL ratio, etc), and pharmacoeconomic outcomes as measured at the Baseline Visit and 90 days later at the Final Visit. Secondarily, to measure the effect of chromium picolinate (600 μg Cr) + biotin (2 mg) versus placebo on patient quality of life, fasting and post-prandial blood sugar levels, fasting insulin, and anti-hyperglycemic medication usage.

Read the detailed description

There will be an Initial Pre-Screening Contact, two office visits (Baseline and Final), and two mid-study phone contacts with the subject during the course of the study. Volunteers will take either chromium picolinate (600 μg Cr) + biotin (2 mg) (n=400) or placebo (n=200) once daily just prior to the morning meal for 90 days. Assessments for glycosylated hemoglobin, lipid profiles, and quality of life will be taken at the Baseline Visit. After 90 days another set of assessments will be taken at the Final Visit for comparison with the baseline values. All subjects will under go a brief physical exam, a medical history assessment, and a comprehensive concomitant medications assessment as well as provide blood and urine samples at the baseline and final visits to ensure subject safety is maintained. The subject will be contacted, by a central call center, between visits at Day 30 and Day 60 to ensure study compliance by reminding the subject to take all doses of study product, perform the daily blood glucose monitoring, and complete the study diary daily.

Being tested
Chromium Picolinate (600 mcg Cr) + biotin (2 mg)
Keywords
chromium, chromium picolinate, type 2 diabetes mellitus, HbA1c, hyperglycemia, cholesterol
Medical subject headings
Diabetes Mellitus, Type 2, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chromium Picolinate (600 mcg Cr) + biotin (2 mg)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c: Baseline and Final Visits

  2. Lipid Panels (Total-C, HDL, LDL, LDL, VLDL, lipid ratios, etc)Baseline and Final Visits

  3. Pharmacoeconomic outcomes (as deduced by changes in HbA1c)

Secondary outcomes (8)

  1. Fasting Plasma Glucose: Baseline and Final Visits

  2. Fasting Insulin: Baseline and Final Visits

  3. HOMA-IR and HOMA-BCF: Baseline and Final Visits

  4. Quality of Life: Baseline and Final Visits

  5. Post Prandial Glucose: Diary recordings of post meal values, 90 day continuous.

  6. Change in Rx Antihyperglycemic agents: Assessed at baseline and compared to final visit.

  7. HAMD-29: Change in depression/mood status; measured at baseline and final at a subset of two research centers. (n~30).

  8. ANCOVAs: Treatment outcomes based on treatment group compared to gender, ethnicity, age, co-morbidities, Rx medications, glycemic states at entrance, lipid status at entrance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2006 (estimated)
  2. Study startMar 2003
  3. Study completionNov 2005

Resources

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
Double blind
Enrolment
600 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00289354
Sponsor's protocol ID
N 21 CPB-02003
Status last verified
Feb 2006
First submitted
7 Feb 2006
Last updated
9 Feb 2006
Results posted
No

Publications

  • Albarracin C, Fuqua B, Geohas J, Juturu V, Finch MR, Komorowski JR. Combination of chromium and biotin improves coronary risk factors in hypercholesterolemic type 2 diabetes mellitus: a placebo-controlled, double-blind randomized clinical trial. J Cardiometab Syndr. 2007 Spring;2(2):91-7. doi: 10.1111/j.1559-4564.2007.06366.x.

    PubMed 17684468

Questions about this trial

What is this clinical trial studying?

A study testing Chromium Picolinate (600 mcg Cr) + biotin (2 mg) in people with Diabetes Mellitus, Type 2, run by Nutrition 21, Inc..

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 9 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: finished, as of the sponsor's last update on 9 Feb 2006. 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 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?

HbA1c: Baseline and Final Visits. The study lists 3 primary outcomes in all. 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 NCT00289354, 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 9 Feb 2006.

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