Clinical trial NCT01738802: The Effects of Micronutrients in Combination With Usual Care in Type 2 Diabetes
Official title: The Effects of Micronutrients in Combination With Usual Care in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
carotid intima medial thickness
micronutrient
anti-oxidant
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
First posted: 2012-11-30
Enrollment: 111
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief 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. 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the markers of oxidative stress and inflammation
timeFrame: baseline, 6, and 12 months
Secondary outcomes:
measure: Change in CIMT
timeFrame: Baseline, 6 and 12 months
measure: Change in medications
timeFrame: Baseline, 3, 6, 9, and 12 months
measure: Change in lipid profile
timeFrame: baseline, 3, 6, 9, and 12 months
measure: Hemoglobin A1c
timeFrame: baseline, 3, 6, 9, and 12 months
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: WRNMMC
name: Robert Vigersky, MD
role: PRINCIPAL_INVESTIGATOR
References: