Diabetes Mellitus, Type 2NCT00308451
A 30 Day Acute Efficacy and Safety Study of Chromium Picolinate + Biotin on Glycemic Control in Overweight or Obese Subjects With T2DM
A study testing Chromium Picolinate (600 mcg Cr+3) + biotin (2 mg) in people with Diabetes Mellitus, Type 2, run by Nutrition 21, Inc. at 1 site in United States.
Trial summary
The purpose of the proposed work is to assess the effects of a dietary supplement, containing chromium (600 mcg per day) provided by chromium picolinate and biotin (2 mg per day) on glycemic control in type 2 diabetes. 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+3) + biotin (2 mg)
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Apr 2004
- 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.
- Post-prandial blood glucose (glucose > 200 mg/dl) levels consistent with an ADA diagnosis of diabetes as confirmed during the screening visit.
- Male and female between the ages of 18 and 65 years.
- HbA1c > 7.0%.
- Use of treatment regimens including diet and exercise and/or drug therapy for diabetes are allowed. Drug therapy may include alpha-glucosidase inhibitors (e.g. acarbose, voglibose, miglitol) and oral hypoglycemic agents such as sulfonylureas and metformin and thiazolidinediones (TZDs). Insulin use is not allowable
- No changes in medication dosage within 60 days prior to entering trial.
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- Subjects with a body mass index (BMI) >25 and < 35.
- Fasting triglycerides < 400. [32]
- 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 I diabetes.
- Hypoglycemic event requiring EMS intervention < 12 months.
- Diabetic Ketoacidosis (DKA) < 12 months.
- Subjects taking any supplement containing chromium within the previous 90 days prior toenrollment.
- Creatinine > 2.0 x ULN; AST or ALT > 2.0 x ULN; Total Bilirubin > 1.5 x ULN.
- COPD, CHF, Angina, HTN, MI, or any other CVD requiring hospitalization within the previous 12 months.
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- History of cerebrovascular accident (CVA), pulmonary embolism (PE), or an unresolved deep vein thrombosis (DVT).
- History of CABG, PTCA, or any other reperfusion therapy < 12 months.
- Uncontrolled high blood pressure (seated: systolic > 160 mmHg or diastolic > 90 mmHg)
- History of any serious immunosuppressive disorder or undergoing current immunosuppressive therapy.
- Female subjects who are pregnant or nursing, or are planning on becoming pregnant during the study. No hormone replacement therapy for post-menopausal subjects.
- Hepatic disease, impaired thyroid, or impaired renal function, or other diseases known to affect glucose or lipid metabolism. TSH must be within range of normality to enter trial.
- Diagnosed or self-reported alcoholism or substance-abuse problems
- Any psychiatric or mental health issue that would prevent the subject from completing 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 participation in any other clinical research trial for any product or device, or participation in said clinical trials within 30 days prior to enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "A Randomized, Double Blinded, Placebo Controlled, Parallel Arm, Study to Evaluate the Improvement in Glycemic Control After Daily Administration of Chromium Picolinate and Biotin in Patients With Type 2 Diabetes Mellitus"
The purpose of the proposed work is to assess the effects of a dietary supplement, containing chromium (600 mcg per day) provided by chromium picolinate and biotin (2 mg per day) on glycemic control in type 2 diabetes. Specifically, this study will assess whether use of the supplement will lower the post-prandial rise in blood glucose experienced after ingestion of a 75g carbohydrate load, relative to placebo, in type 2 diabetic patients. The study will also assess the chronic effects of supplementation over a 4-week period (relative to placebo) on fasting plasma levels of glucose, insulin, lipids and lipoproteins.
Read the detailed description
The purpose of this work is to assess the effects of a dietary supplement, containing chromium (600 mcg per day) provided by chromium picolinate and biotin (2 mg per day) on glycemic control in type 2 diabetes who are currently taking an oral antidiabetic agent (OAD) and failing therapy with OADs. Subjects entering the trial must have a HbA1c >/= 7.0% and have an OGTT >/= 200 mg/dL at 2 hours post consumption of a 75 g glucose beverage. The study is an acute 30 day intervention in conjunction with the subject's current OADs and standard of care in comparison to placebo.
Specifically, this study will assess whether use of the supplement will lower the post-prandial rise in blood glucose experienced after ingestion of a 75g carbohydrate load, relative to placebo, in type 2 diabetic patients as measured by the area under the curve for glucose (AUCg). The study will also assess the acute effects of supplementation over a 4-week period (relative to placebo) on fasting plasma levels of glucose, fructosamine, insulin, lipids and lipoproteins.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Chromium Picolinate (600 mcg Cr+3) + biotin (2 mg)
- Keywords
- chromium, chromium picolinate, type 2 diabetes mellitus, fructosamine, glycemic control, OGTT
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chromium Picolinate (600 mcg Cr+3) + biotin (2 mg)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary(baseline versus final): AUCg as recorded from a 2-hour OGTT with 75 g glucose beverage; fructosamine; fasting plasma glucose.
Secondary outcomes (1)
Secondary (baseline versus final): Lipid panels (Total-C, HDL, LDL, VLDL), lipid ratios , apolipoprotein A and B.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2006 (estimated)
- Study startNov 2003
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Nutrition 21, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jeffery Geohas, MD, Principal investigator, Radiant Research - Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308451
- Sponsor's protocol ID
- N21 CPB-03001
- Status last verified
- Mar 2006
- First submitted
- 27 Mar 2006
- Last updated
- 29 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "A Randomized, Double Blinded, Placebo Controlled, Parallel Arm, Study to Evaluate the Improvement in Glycemic Control After Daily Administration of Chromium Picolinate and Biotin in Patients With Type 2 Diabetes Mellitus"
- ClinicalTrials.gov ID
- NCT00308451
- Acronym / sponsor ID
- N21 CPB-03001
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- chromium, chromium picolinate, type 2 diabetes mellitus, fructosamine, glycemic control, OGTT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Nutrition 21, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2003
- Study completion
- Apr 2004
- First posted
- 29 Mar 2006 (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 purpose of the proposed work is to assess the effects of a dietary supplement, containing chromium (600 mcg per day) provided by chromium picolinate and biotin (2 mg per day) on glycemic control in type 2 diabetes. Specifically, this study will assess whether use of the supplement will lower the post-prandial rise in blood glucose experienced after ingestion of a 75g carbohydrate load, relative to placebo, in type 2 diabetic patients. The study will also assess the chronic effects of supplementation over a 4-week period (relative to placebo) on fasting plasma levels of glucose, insulin, lipids and lipoproteins.
Detailed description
The purpose of this work is to assess the effects of a dietary supplement, containing chromium (600 mcg per day) provided by chromium picolinate and biotin (2 mg per day) on glycemic control in type 2 diabetes who are currently taking an oral antidiabetic agent (OAD) and failing therapy with OADs. Subjects entering the trial must have a HbA1c >/= 7.0% and have an OGTT >/= 200 mg/dL at 2 hours post consumption of a 75 g glucose beverage. The study is an acute 30 day intervention in conjunction with the subject's current OADs and standard of care in comparison to placebo.
Specifically, this study will assess whether use of the supplement will lower the post-prandial rise in blood glucose experienced after ingestion of a 75g carbohydrate load, relative to placebo, in type 2 diabetic patients as measured by the area under the curve for glucose (AUCg). The study will also assess the acute effects of supplementation over a 4-week period (relative to placebo) on fasting plasma levels of glucose, fructosamine, insulin, lipids and lipoproteins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of type 2 diabetes > 12 months.
- Post-prandial blood glucose (glucose > 200 mg/dl) levels consistent with an ADA diagnosis of diabetes as confirmed during the screening visit.
- Male and female between the ages of 18 and 65 years.
- HbA1c > 7.0%.
- Use of treatment regimens including diet and exercise and/or drug therapy for diabetes are allowed. Drug therapy may include alpha-glucosidase inhibitors (e.g. acarbose, voglibose, miglitol) and oral hypoglycemic agents such as sulfonylureas and metformin and thiazolidinediones (TZDs). Insulin use is not allowable
Key exclusion criteria (16 listed)
- Diagnosis of type I diabetes.
- Hypoglycemic event requiring EMS intervention < 12 months.
- Diabetic Ketoacidosis (DKA) < 12 months.
- Subjects taking any supplement containing chromium within the previous 90 days prior toenrollment.
- Creatinine > 2.0 x ULN; AST or ALT > 2.0 x ULN; Total Bilirubin > 1.5 x ULN.
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 |
|---|---|---|
| Chromium Picolinate (600 mcg Cr+3) + biotin (2 mg) | Drug | – |
Primary outcome
Primary(baseline versus final): AUCg as recorded from a 2-hour OGTT with 75 g glucose beverage; fructosamine; fasting plasma glucose.
1 secondary outcome
Secondary (baseline versus final): Lipid panels (Total-C, HDL, LDL, VLDL), lipid ratios , apolipoprotein A and B.
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 29 Mar 2006.
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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.
Jeffery Geohas, MD principal investigator
Radiant Research - Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chromium Picolinate (600 mcg Cr+3) + biotin (2 mg) in people with Diabetes Mellitus, Type 2, run by Nutrition 21, Inc. 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 10 inclusion and 16 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 29 Mar 2006. 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 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?
Primary(baseline versus final): AUCg as recorded from a 2-hour OGTT with 75 g glucose beverage; fructosamine; fasting plasma glucose.. 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 29 Mar 2006.