The Effects of Micronutrients in Combination With Usual Care in Type 2 Diabetes
Status: | Completed |
---|---|
Conditions: | Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 4/29/2016 |
Start Date: | January 2012 |
End Date: | April 2016 |
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.
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.
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).
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).
Inclusion Criteria:
1. Patients with a diagnosis of Type 2 diabetes of at least three months duration
2. 50 years of age or older
3. Stable medical status (e.g., no myocardial infarction, stroke, major surgery, or
major mental illness during the previous six months)
4. 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
5. Not receiving chemotherapy or immunosuppressive therapy
6. Military healthcare beneficiary
Exclusion Criteria:
1. Patients with Type 1 diabetes or those with Type 2 diabetes of less than 3 months
duration.
2. Inability to communicate in written and spoken English
3. Organ (kidney, pancreas, liver) transplant recipients
4. 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
5. 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).
6. 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.
We found this trial at
2
sites
8901 Rockville Pike
Bethesda, Maryland 20889
Bethesda, Maryland 20889
(301) 295-4000

Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
Click here to add this to my saved trials

8901 Rockville Pike
Bethesda, Maryland 20889
Bethesda, Maryland 20889
(301) 295-4000

Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
Click here to add this to my saved trials
