A 30 Day Acute Efficacy and Safety Study of Chromium Picolinate + Biotin on Glycemic Control in Overweight or Obese Subjects With T2DM
NCT ID: NCT00308451
Last Updated: 2006-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
40 participants
INTERVENTIONAL
2003-11-30
2004-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Chromium Picolinate (600 mcg Cr+3) + biotin (2 mg)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Post-prandial blood glucose (glucose \> 200 mg/dl) levels consistent with an ADA diagnosis of diabetes as confirmed during the screening visit.
3. Male and female between the ages of 18 and 65 years.
4. HbA1c \> 7.0%.
5. 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
6. No changes in medication dosage within 60 days prior to entering trial.
7. Subjects with a body mass index (BMI) \>25 and \< 35.
8. Fasting triglycerides \< 400. \[32\]
9. Willing to complete all study related requirements.
10. Subject will provide written consent to participate in the trial and this consent must be given voluntarily.
Exclusion Criteria
2. Hypoglycemic event requiring EMS intervention \< 12 months.
3. Diabetic Ketoacidosis (DKA) \< 12 months.
4. Subjects taking any supplement containing chromium within the previous 90 days prior toenrollment.
5. Creatinine \> 2.0 x ULN; AST or ALT \> 2.0 x ULN; Total Bilirubin \> 1.5 x ULN.
6. COPD, CHF, Angina, HTN, MI, or any other CVD requiring hospitalization within the previous 12 months.
7. History of cerebrovascular accident (CVA), pulmonary embolism (PE), or an unresolved deep vein thrombosis (DVT).
8. History of CABG, PTCA, or any other reperfusion therapy \< 12 months.
9. Uncontrolled high blood pressure (seated: systolic \> 160 mmHg or diastolic \> 90 mmHg)
10. History of any serious immunosuppressive disorder or undergoing current immunosuppressive therapy.
11. Female subjects who are pregnant or nursing, or are planning on becoming pregnant during the study. No hormone replacement therapy for post-menopausal subjects.
12. 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.
13. Diagnosed or self-reported alcoholism or substance-abuse problems
14. Any psychiatric or mental health issue that would prevent the subject from completing the study
15. 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.
16. 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.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nutrition 21, Inc.
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jeffery Geohas, MD
Role: PRINCIPAL_INVESTIGATOR
Radiant Research - Chicago
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Radiant Research Chicago
Chicago, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
N21 CPB-03001
Identifier Type: -
Identifier Source: org_study_id