Type 2 DiabetesPMCNCT01738802
The Effects of Micronutrients in Combination With Usual Care in Type 2 Diabetes
A study testing Anti-oxidant and micronutrient in people with Type 2 Diabetes, run by Walter Reed National Military Medical Center at 2 sites in United States.
Trial summary
This study is evaluating the impact of antioxidant supplements on blood sugar control and cardiovascular risk factors in adults over the age of 50 with at 3 months of Type 2 diabetes. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Anti-oxidant and micronutrient
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to Apr 2016
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of Type 2 diabetes of at least three months duration
- 50 years of age or older
- Stable medical status (e.g., no myocardial infarction, stroke, major surgery, or major mental illness during the previous six months)
- Not taking or not expected to be taking any oral glucocorticoids (except for replacement therapy for those with adrenal insufficiency), amphetamines, anabolic, or weight-reducing agents during the course of the study
- Not receiving chemotherapy or immunosuppressive therapy
- Military healthcare beneficiary
Who cannot join
- Patients with Type 1 diabetes or those with Type 2 diabetes of less than 3 months duration.
- Inability to communicate in written and spoken English
- Organ (kidney, pancreas, liver) transplant recipients
- Individuals who are not likely to return for the follow-up because they or their sponsors are likely to have a permanent change of station or termination of service before completion of the protocol
- Pregnancy (Women who are pre-menopausal will be informed that pregnancy must be ruled out by a serum HCG test if they would like to be considered for participation in the study. Women who have had a hysterectomy or have not had a menstrual period for at least one year prior to consent will be considered post-menopausal and will not require a serum pregnancy test).
- Patients who are routinely taking more than 81 mg aspirin (ASA)/day or who are using ASA or ASA-containing products to manage a chronic condition.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
This study is evaluating the impact of antioxidant supplements on blood sugar control and cardiovascular risk factors in adults over the age of 50 with at 3 months of Type 2 diabetes. The investigators hypothesize that daily supplementation with a multiple micronutrient formulation containing dietary and endogenous antioxidants in combination with usual care will reduce markers of oxidative stress and inflammation in Type 2 diabetes.
Read the detailed description
This study is evaluating the impact of an antioxidant and micronutrient supplement on markers of oxidative stress and inflammation as well as on blood sugar control in adults over the age of 50 who have had Type 2 diabetes for at least 3 months. The purpose of this study is to see if these antioxidants reduce the oxidative and inflammatory state seen in patients with Type 2 diabetes as well as whether or not they make it easier to control blood sugar, affect the number and dosage of diabetic medications, and/or reduce the risk factors involved in long-term diabetes related complications such as in lipid profile and carotid intima-media thickness (CIMT).
- Conditions
- Type 2 Diabetes
- Being tested
- Anti-oxidant and micronutrient, Placebo
- Keywords
- Type 2 Diabetes, carotid intima medial thickness, micronutrient, anti-oxidant
- 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.
Anti-oxidant and micronutrientDietary supplement
This group will be randomized to take the anti-oxidant and micronutrient supplement.
PlaceboDrug
This group will take a placebo.
| Study group | Role | What they receive |
|---|---|---|
| Anti-oxidant and micronutrient | Experimental | This group will take the anti-oxidant and micronutrient supplement. Receives: Dietary Supplement: Anti-oxidant and micronutrient |
| Placebo | Placebo comparator | This group will take the placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the markers of oxidative stress and inflammation
Determining a difference between the control and experimental groups in the following markers of 1) oxidative stress: 9-Malondialdehyde (MDA) in plasma, 3-Nitrotyrosine in plasma, and Urinary levels of F2-isoprostane and 8 hydroxy,deoxyguanosine; and 2) inflammation: GM-CSF, IFN-γ, IL-1β, IL-2, L-4, IL-5, IL-6, IL-10, IL-12 (p40/p70), TNF-α.
Measured: baseline, 6, and 12 months
Secondary outcomes (4)
Change in CIMT
Determine if a difference exists in CIMT measurements between the control and experimental groups.
Measured: Baseline, 6 and 12 months
Change in medications
Compare the experimental and control groups to determine if medication use has changed over the course of the study.
Measured: Baseline, 3, 6, 9, and 12 months
Change in lipid profile
Compare the control and experimental groups to determine differences in lipid profile over time.
Measured: baseline, 3, 6, 9, and 12 months
Hemoglobin A1c
Determine the difference in quarterly A1c measurements between the experimental and control groups over the course of the study.
Measured: baseline, 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startJan 2012
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Alicia L. Warnock, Walter Reed National Military Medical Center
- Investigators
- Robert Vigersky, MD, Principal investigator, WRNMMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738802
- Sponsor's protocol ID
- 361813
- Acronym
- PMC
- Status last verified
- Apr 2016
- First submitted
- 19 Jul 2012
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Micronutrients in Combination With Usual Care in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01738802
- Acronym / sponsor ID
- PMC / 361813
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, carotid intima medial thickness, micronutrient, anti-oxidant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- Jan 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 30 Nov 2012 (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.
This study is evaluating the impact of antioxidant supplements on blood sugar control and cardiovascular risk factors in adults over the age of 50 with at 3 months of Type 2 diabetes. The investigators hypothesize that daily supplementation with a multiple micronutrient formulation containing dietary and endogenous antioxidants in combination with usual care will reduce markers of oxidative stress and inflammation in Type 2 diabetes.
Detailed description
This study is evaluating the impact of an antioxidant and micronutrient supplement on markers of oxidative stress and inflammation as well as on blood sugar control in adults over the age of 50 who have had Type 2 diabetes for at least 3 months. The purpose of this study is to see if these antioxidants reduce the oxidative and inflammatory state seen in patients with Type 2 diabetes as well as whether or not they make it easier to control blood sugar, affect the number and dosage of diabetic medications, and/or reduce the risk factors involved in long-term diabetes related complications such as in lipid profile and carotid intima-media thickness (CIMT).
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-oxidant and micronutrient | Experimental | Dietary Supplement: Anti-oxidant and micronutrientThis group will take the anti-oxidant and micronutrient supplement. |
| Placebo | Placebo comparator | Drug: PlaceboThis group will take the placebo. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with a diagnosis of Type 2 diabetes of at least three months duration
- 50 years of age or older
- Stable medical status (e.g., no myocardial infarction, stroke, major surgery, or major mental illness during the previous six months)
- Not taking or not expected to be taking any oral glucocorticoids (except for replacement therapy for those with adrenal insufficiency), amphetamines, anabolic, or weight-reducing agents during the course of the study
- Not receiving chemotherapy or immunosuppressive therapy
Key exclusion criteria (6 listed)
- Patients with Type 1 diabetes or those with Type 2 diabetes of less than 3 months duration.
- Inability to communicate in written and spoken English
- Organ (kidney, pancreas, liver) transplant recipients
- Individuals who are not likely to return for the follow-up because they or their sponsors are likely to have a permanent change of station or termination of service before completion of the protocol
- Pregnancy (Women who are pre-menopausal will be informed that pregnancy must be ruled out by a serum HCG test if they would like to be considered for participation in the study. Women who have had a hysterectomy or have not had a menstrual period for at least one year prior to consent will be considered post-menopausal and will not require a serum pregnancy test).
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 |
|---|---|---|
| Anti-oxidant and micronutrientThis group will be randomized to take the anti-oxidant and micronutrient supplement. | Dietary supplement | Anti-oxidant and micronutrient |
| PlaceboThis group will take a placebo. | Drug | Placebo |
Primary outcome
Change in the markers of oxidative stress and inflammation
Time frame: baseline, 6, and 12 months
Determining a difference between the control and experimental groups in the following markers of 1) oxidative stress: 9-Malondialdehyde (MDA) in plasma, 3-Nitrotyrosine in plasma, and Urinary levels of F2-isoprostane and 8 hydroxy,deoxyguanosine; and 2) inflammation: GM-CSF, IFN-γ, IL-1β, IL-2, L-4, IL-5, IL-6, IL-10, IL-12 (p40/p70), TNF-α.
4 secondary outcomes
Change in CIMT
Time frame: Baseline, 6 and 12 months
Change in medications
Time frame: Baseline, 3, 6, 9, and 12 months
Change in lipid profile
Time frame: baseline, 3, 6, 9, and 12 months
Hemoglobin A1c
Time frame: baseline, 3, 6, 9, and 12 months
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 28 Apr 2016.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Robert Vigersky, MD principal investigator
WRNMMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-oxidant and micronutrient in people with Type 2 Diabetes, run by Walter Reed National Military Medical Center at 2 sites 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 6 inclusion and 6 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 28 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 2 sites 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. Some participants in this study may receive a placebo. 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?
Change in the markers of oxidative stress and inflammation (time frame: baseline, 6, and 12 months). 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 28 Apr 2016.