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Effects of Micronutrient (Chromium) Supplementation on Diabetes

Ketosis, Vascular Inflammation, and Its Therapy (Chromium Supplementation) in Diabetic Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01709123
Enrollment
62
Registered
2012-10-17
Start date
2007-08-31
Completion date
2013-09-30
Last updated
2022-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Juvenile Onset, Cardiovascular Diseases, Hyperglycemia, Hyperketonemia

Brief summary

6-8% of USA population has diabetes. Intensive blood glucose control dramatically reduces the devastating complications that result from poorly controlled diabetes. However, for many patients, achievement of tight glucose control is difficult with current regimens. Trivalent chromium, the form found in foods and dietary supplements, is believed to be safe. Our preliminary studies have reported that chromium supplementation inhibits the increase in pro-inflammatory cytokines (tumor necrosis factor-alpha and interleukin-6; TNF-alpha and IL-6) secretion levels caused by high glucose levels in cultured monocytic cells. Similarly, animal studies have shown that chromium niacinate supplementation lowered blood levels of glycemia and pro-inflammatory cytokines in streptozotocin-treated diabetic rats. Cytokines are proteins that are secreted by monocytes and other cells in response to various stimuli, such as infection. Some of the cytokines are known to regulate insulin sensitivity and elevated level of these cytokines in blood may accelerate clogging of arteries. Thus, chromium supplementation may increase insulin sensitivity and glycemic control in diabetic patients, and may prevent the development of cardiovascular disease in diabetic patients. Given the enormous public health cost of diabetes, the prospect of being able to use a relatively low-cost dietary supplement, such as chromium, as an adjuvant therapy to help in achieving normal blood glucose level merits further study. We will examine the effects of placebo and chromium niacinate supplementation on the fasting glucose, cholesterol, triglycerides, and markers of vascular disease in blood of diabetic patients. We will determine these above parameters at baseline and after the 1, 2 and 3 months of supplementation in diabetic patients. The long-term objective is to explore the efficacy of chromium as an adjuvant treatment for better glycemic control, prevent the development of cardiovascular disease (CVD), and improve the life expectancy in diabetic population. Chromium supplements are widely used by the public and are available in many stores, such as Wal-mart, Walgreens, and many other food and drug stores. Chromium is an essential trace metal and micronutrient present in wide variety of vegetables. Niacin is a vitamin B6, an essential vitamin for our body. This study plans to use chromium niacinate, a complex of chromium and niacin. Chromium niacinate is considered a nutrient.

Interventions

DRUGchromium niacinate

200ug or 500ug supplementation in pill form

DRUGplacebo

Placebo pill for chromium niacinate

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Louisiana State University Health Sciences Center Shreveport
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
8 Years to 21 Years
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of Type 1 diabetes mellitus * Participants between the ages of 8 and 21

Exclusion criteria

* Subjects with sickle cell disease, renal or liver disease * Serum positive pregnancy test or breastfeeding * Participants unwilling/unable to take supplements in pill form * Participants taking prescription medication or supplements

Design outcomes

Primary

MeasureTime frameDescription
Blood Glucose LevelAssessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.Measuring levels of glycemia (fasting glucose) in blood of patients in the placebo group and the chromium supplement group.
Blood Glucose LevelsAssessed for 16 weeks with five measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks). 16 weeks reported.Measuring levels of glycemia (HbA1c) in blood patients in the placebo group and the chromium supplement group.

Secondary

MeasureTime frameDescription
Lipid LevelsAssessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.Measuring levels of TG (triglycerides), LDL and HDL-cholesterol in blood of patients in the placebo group and the chromium supplement group.
Blood Levels of Cytokines/Inflammatory BiomarkersAssessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.Measuring levels of reactive oxygen species (ROS) in blood of patients in the placebo group and chromium supplement group.

Countries

United States

Participant flow

Participants by arm

ArmCount
Placebo
Placebo supplementation in pill form for 3 months following randomization after a placebo run-in period. placebo: Placebo pill for chromium niacinate
22
Chromium Niacinate
Chromium niacinate supplementation (200ug or 500ug/day) in pill form for 3 months following randomization after a placebo run-in period chromium niacinate: 200ug or 500ug supplementation in pill form
22
Total44

Baseline characteristics

CharacteristicChromium NiacinateTotalPlacebo
Age, Categorical
<=18 years
20 Participants40 Participants20 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
2 Participants4 Participants2 Participants
Race and Ethnicity Not Collected0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
6 Participants13 Participants7 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
16 Participants31 Participants15 Participants
Region of Enrollment
United States
22 Participants44 Participants22 Participants
Sex: Female, Male
Female
13 Participants22 Participants9 Participants
Sex: Female, Male
Male
9 Participants22 Participants13 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 220 / 22
other
Total, other adverse events
0 / 220 / 22
serious
Total, serious adverse events
0 / 220 / 22

Outcome results

Primary

Blood Glucose Level

Measuring levels of glycemia (fasting glucose) in blood of patients in the placebo group and the chromium supplement group.

Time frame: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboBlood Glucose LevelFigures:16 weeks164.47 mg/dLStandard Error 16.187
PlaceboBlood Glucose LevelBaseline Figures172.39 mg/dLStandard Error 20.641
Chromium NiacinateBlood Glucose LevelBaseline Figures212.85 mg/dLStandard Error 21.153
Chromium NiacinateBlood Glucose LevelFigures:16 weeks191.25 mg/dLStandard Error 21.363
Primary

Blood Glucose Levels

Measuring levels of glycemia (HbA1c) in blood patients in the placebo group and the chromium supplement group.

Time frame: Assessed for 16 weeks with five measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks). 16 weeks reported.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboBlood Glucose LevelsBaseline Figures9.5667 mmol/molStandard Error 0.4708
PlaceboBlood Glucose LevelsFigures: 16 weeks9.2267 mmol/molStandard Error 0.4396
Chromium NiacinateBlood Glucose LevelsBaseline Figures9.7368 mmol/molStandard Error 0.4888
Chromium NiacinateBlood Glucose LevelsFigures: 16 weeks9.5606 mmol/molStandard Error 0.4839
Secondary

Blood Levels of Cytokines/Inflammatory Biomarkers

Measuring levels of Leptin in blood of patients in the placebo group and chromium supplement group.

Time frame: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboBlood Levels of Cytokines/Inflammatory BiomarkersBaseline Leptin values16.715 ug/mLStandard Error 4.2746
PlaceboBlood Levels of Cytokines/Inflammatory BiomarkersLeptin: 16 weeks15.885 ug/mLStandard Error 4.1824
Chromium NiacinateBlood Levels of Cytokines/Inflammatory BiomarkersBaseline Leptin values16.263 ug/mLStandard Error 3.3631
Chromium NiacinateBlood Levels of Cytokines/Inflammatory BiomarkersLeptin: 16 weeks14.776 ug/mLStandard Error 3.1102
Secondary

Blood Levels of Cytokines/Inflammatory Biomarkers

Measuring levels of C reactive protein (CRP) in blood of patients in the placebo group and chromium supplement group.

Time frame: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboBlood Levels of Cytokines/Inflammatory BiomarkersBaseline CRP values185.20 ug/mLStandard Error 9.8926
PlaceboBlood Levels of Cytokines/Inflammatory BiomarkersCRP values: 16 weeks182.98 ug/mLStandard Error 9.558
Chromium NiacinateBlood Levels of Cytokines/Inflammatory BiomarkersBaseline CRP values186.48 ug/mLStandard Error 7.6407
Chromium NiacinateBlood Levels of Cytokines/Inflammatory BiomarkersCRP values: 16 weeks185.11 ug/mLStandard Error 8.6807
Secondary

Blood Levels of Cytokines/Inflammatory Biomarkers

Measuring levels of reactive oxygen species (ROS) in blood of patients in the placebo group and chromium supplement group.

Time frame: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboBlood Levels of Cytokines/Inflammatory BiomarkersBaseline ROS values53587.3 mean fluorescent unitStandard Error 1471.25
PlaceboBlood Levels of Cytokines/Inflammatory BiomarkersROS values:16 weeks56864.8 mean fluorescent unitStandard Error 1474.31
Chromium NiacinateBlood Levels of Cytokines/Inflammatory BiomarkersBaseline ROS values51877.2 mean fluorescent unitStandard Error 977.774
Chromium NiacinateBlood Levels of Cytokines/Inflammatory BiomarkersROS values:16 weeks53577.0 mean fluorescent unitStandard Error 2970.86
Secondary

Blood Levels of Cytokines/Inflammatory Biomarkers

Measuring levels of Interleukin-6 (IL-6) in blood of patients in the placebo group and chromium supplement group.

Time frame: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboBlood Levels of Cytokines/Inflammatory BiomarkersBaseline Interleukin-6 Values1.6795 ug/mLStandard Error 0.1801
PlaceboBlood Levels of Cytokines/Inflammatory BiomarkersInterleukin-6 Values: 16 weeks2.0290 ug/mLStandard Error 0.4057
Chromium NiacinateBlood Levels of Cytokines/Inflammatory BiomarkersBaseline Interleukin-6 Values1.7754 ug/mLStandard Error 0.1848
Chromium NiacinateBlood Levels of Cytokines/Inflammatory BiomarkersInterleukin-6 Values: 16 weeks2.0000 ug/mLStandard Error 0.3527
Secondary

Lipid Levels

Measuring levels of TG (triglycerides), LDL and HDL-cholesterol in blood of patients in the placebo group and the chromium supplement group.

Time frame: Assessed for 16 weeks with 5 measurements. (0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks), 16 weeks reported.

ArmMeasureGroupValue (MEAN)Dispersion
PlaceboLipid LevelsBaseline Cholesterol values165.50 mg/dLStandard Error 10.095
PlaceboLipid LevelsCholesterol values:16 weeks158.87 mg/dLStandard Error 7.6
PlaceboLipid LevelsBaseline HDL values50.944 mg/dLStandard Error 2.7871
PlaceboLipid LevelsHDL values:16 weeks49.733 mg/dLStandard Error 2.6806
PlaceboLipid LevelsBaseline LDL values96.000 mg/dLStandard Error 7.7147
PlaceboLipid LevelsLDL values:16 weeks93.867 mg/dLStandard Error 7.217
PlaceboLipid LevelsBaseline triglyceride values92.333 mg/dLStandard Error 10.538
PlaceboLipid LevelsTriglyceride values:16 weeks77.200 mg/dLStandard Error 6.0688
Chromium NiacinateLipid LevelsTriglyceride values:16 weeks81.722 mg/dLStandard Error 14.557
Chromium NiacinateLipid LevelsBaseline Cholesterol values160.42 mg/dLStandard Error 7.1301
Chromium NiacinateLipid LevelsBaseline LDL values87.579 mg/dLStandard Error 5.5442
Chromium NiacinateLipid LevelsCholesterol values:16 weeks164.78 mg/dLStandard Error 9.1092
Chromium NiacinateLipid LevelsBaseline triglyceride values91.105 mg/dLStandard Error 13.914
Chromium NiacinateLipid LevelsBaseline HDL values53.842 mg/dLStandard Error 3.1122
Chromium NiacinateLipid LevelsLDL values:16 weeks93.556 mg/dLStandard Error 6.4409
Chromium NiacinateLipid LevelsHDL values:16 weeks54.889 mg/dLStandard Error 3.1425

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026