Type 2 DiabetesPhase 4NCT00398853
Effect of Chromium Picolinate on Insulin Sensitivity in Type 2 Diabetes
A Phase 4 study of Type 2 Diabetes, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
The effect of Chromium to improve glucose levels in diabetes is controversial. The hypothesis of the study was to evaluate the effect of supplementing the diet of individuals with Type 2 diabetes with chromium picolinate and assessing the effect of the supplementation on insulin sensitivity as assessed with… Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Type 2 Diabetes
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Jun 2009
- Phase
- Phase 4
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- On no meds to alter glucose metabolism
- age greater than 25 years old
- Fasting glucose greater than 125 mg/dl at screening
Who cannot join
- Subjects on insulin
- Sujbects on meds that alter glucose metabolism
- Use of glitazones
- C0-existing disorders in major organ systems such as heart, kidneys, liver
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Chromium and Insulin Action
The effect of Chromium to improve glucose levels in diabetes is controversial. The hypothesis of the study was to evaluate the effect of supplementing the diet of individuals with Type 2 diabetes with chromium picolinate and assessing the effect of the supplementation on insulin sensitivity as assessed with hyperinsulinemic clamps
Read the detailed description
Detailed Description:
The primary clinical strategy to improve metabolic control in patients with Type 2 diabetes consists of lifestyle modification combined with pharmacologic intervention. However, alternative strategies, e.g. nutritional supplementation with over-the-counter agents, are extensively practiced by a large number of patients and are frequently undertaken without first informing the medical provider. Unfortunately, considerable controversy exists regarding use of dietary supplements in subjects with diabetes because efficacy data for many of the supplements consists of only uncontrolled studies and anecdotal reports. As such, there is a paucity of data in humans in regard to the effect of most commercially available supplements to improve metabolic abnormalities.
One supplement that has attracted considerable clinical interest is chromium (Cr). However, routine use of Cr in subjects with diabetes is not currently recommended. In part, the controversy surrounding Cr supplementation stems from the lack of definitive randomized trials, the lack of "gold standard" techniques to assess glucose metabolism in the studies reported, the use of differing doses and formulation , and the study of heterogeneous study populations. As such, conflicting data has been reported that has contributed greatly to the confusion among healthcare providers concerning Cr supplementation. In order to provide a comprehensive clinical evaluation of Cr, we conducted a randomized, double-blinded, placebo-controlled trial in subjects with Type 2 diabetes. Individuals had baseline measures consisting of oral glucose tolerance testing, body fat and adiposity assessed, and then used established techniques to assess insulin sensitivity with hyperinsulinemic-euglycemic clamps. Individuals were evaluated for 6 months at which time repeat testing was done.
- Conditions
- Type 2 Diabetes
- Being tested
- chromium picolinate 1000 mcg daily vs placebo, Placebo
- Keywords
- insulin, glucose, chromium
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chromium picolinate 1000 mcg daily vs placeboDietary supplement
chromium picolinate 1000 mcg daily vs placebo
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Chromium Picolinate | Experimental | Chromium Receives: Dietary Supplement: chromium picolinate 1000 mcg daily vs placebo |
| Placebo | Other | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity as assessed with hyperinsulinemic-euglycemic clamps
Measured: at study enpoints
Secondary outcomes (2)
glucose control
Measured: at study endpoints
body weight and fat distribution, myocellular and intrahepatic lipid content as assessed with MRS scans
Measured: at study endpoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startOct 2003
- Primary completionApr 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Cefalu, MD, Pennington Biomedical Research Center
- Investigators
- William Cefalu, MD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398853
- Sponsor's protocol ID
- 1R01DK060126
- Status last verified
- Apr 2016
- First submitted
- 9 Nov 2006
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Broskey NT, Obanda DN, Burton JH, Cefalu WT, Ravussin E. Skeletal muscle ceramides and daily fat oxidation in obesity and diabetes. Metabolism. 2018 May;82:118-123. doi: 10.1016/j.metabol.2017.12.012. Epub 2018 Jan 4.
PubMed 29307520Cefalu WT, Rood J, Pinsonat P, Qin J, Sereda O, Levitan L, Anderson RA, Zhang XH, Martin JM, Martin CK, Wang ZQ, Newcomer B. Characterization of the metabolic and physiologic response to chromium supplementation in subjects with type 2 diabetes mellitus. Metabolism. 2010 May;59(5):755-62. doi: 10.1016/j.metabol.2009.09.023. Epub 2009 Dec 22.
PubMed 20022616
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chromium and Insulin Action
- ClinicalTrials.gov ID
- NCT00398853
- Acronym / sponsor ID
- 1R01DK060126
- Conditions
- Type 2 Diabetes
- Keywords
- insulin, glucose, chromium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 14 Nov 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 effect of Chromium to improve glucose levels in diabetes is controversial. The hypothesis of the study was to evaluate the effect of supplementing the diet of individuals with Type 2 diabetes with chromium picolinate and assessing the effect of the supplementation on insulin sensitivity as assessed with hyperinsulinemic clamps
Detailed description
Detailed Description:
The primary clinical strategy to improve metabolic control in patients with Type 2 diabetes consists of lifestyle modification combined with pharmacologic intervention. However, alternative strategies, e.g. nutritional supplementation with over-the-counter agents, are extensively practiced by a large number of patients and are frequently undertaken without first informing the medical provider. Unfortunately, considerable controversy exists regarding use of dietary supplements in subjects with diabetes because efficacy data for many of the supplements consists of only uncontrolled studies and anecdotal reports. As such, there is a paucity of data in humans in regard to the effect of most commercially available supplements to improve metabolic abnormalities.
One supplement that has attracted considerable clinical interest is chromium (Cr). However, routine use of Cr in subjects with diabetes is not currently recommended. In part, the controversy surrounding Cr supplementation stems from the lack of definitive randomized trials, the lack of "gold standard" techniques to assess glucose metabolism in the studies reported, the use of differing doses and formulation , and the study of heterogeneous study populations. As such, conflicting data has been reported that has contributed greatly to the confusion among healthcare providers concerning Cr supplementation. In order to provide a comprehensive clinical evaluation of Cr, we conducted a randomized, double-blinded, placebo-controlled trial in subjects with Type 2 diabetes. Individuals had baseline measures consisting of oral glucose tolerance testing, body fat and adiposity assessed, and then used established techniques to assess insulin sensitivity with hyperinsulinemic-euglycemic clamps. Individuals were evaluated for 6 months at which time repeat testing was done.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chromium Picolinate | Experimental | Dietary Supplement: chromium picolinate 1000 mcg daily vs placeboChromium |
| Placebo | Other | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes
- On no meds to alter glucose metabolism
- age greater than 25 years old
- Fasting glucose greater than 125 mg/dl at screening
Key exclusion criteria (4 listed)
- Subjects on insulin
- Sujbects on meds that alter glucose metabolism
- Use of glitazones
- C0-existing disorders in major organ systems such as heart, kidneys, liver
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 1000 mcg daily vs placebochromium picolinate 1000 mcg daily vs placebo | Dietary supplement | Chromium Picolinate |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Insulin Sensitivity as assessed with hyperinsulinemic-euglycemic clamps
Time frame: at study enpoints
2 secondary outcomes
glucose control
Time frame: at study endpoints
body weight and fat distribution, myocellular and intrahepatic lipid content as assessed with MRS scans
Time frame: at study endpoints
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 8 Apr 2016.
- Derived from this study: PubMed 29307520Broskey NT, Obanda DN, Burton JH, Cefalu WT, Ravussin E. Skeletal muscle ceramides and daily fat oxidation in obesity and diabetes. Metabolism. 2018 May;82:118-123. doi: 10.1016/j.metabol.2017.12.012. Epub 2018 Jan 4.
- Derived from this study: PubMed 20022616Cefalu WT, Rood J, Pinsonat P, Qin J, Sereda O, Levitan L, Anderson RA, Zhang XH, Martin JM, Martin CK, Wang ZQ, Newcomer B. Characterization of the metabolic and physiologic response to chromium supplementation in subjects with type 2 diabetes mellitus. Metabolism. 2010 May;59(5):755-62. doi: 10.1016/j.metabol.2009.09.023. Epub 2009 Dec 22.
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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.
William Cefalu, MD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Type 2 Diabetes, run by Pennington Biomedical Research Center 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 4 inclusion and 4 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 8 Apr 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Insulin Sensitivity as assessed with hyperinsulinemic-euglycemic clamps (time frame: at study enpoints). 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 NCT00398853, which also lists 2 linked publications.
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 8 Apr 2016.