The Effects of Micronutrients in Combination With Usual Care in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— PMC  

Official title:

The Effects of Micronutrients in Combination With Usual Care in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01738802
• Other study ID #: 361813
• Status: Completed
• Phase: N/A
• First received: July 19, 2012
• Last updated: April 27, 2016
• Start date: January 2012
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Walter Reed National Military Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Anti-oxidant and micronutrient
This group will be randomized to take the anti-oxidant and micronutrient supplement.

Drug:
• Placebo
This group will take a placebo.

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Walter Reed National Military Medical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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-?, IL-1ß, IL-2, L-4, IL-5, IL-6, IL-10, IL-12 (p40/p70), TNF-a.	baseline, 6, and 12 months	No
Secondary	Change in CIMT	Determine if a difference exists in CIMT measurements between the control and experimental groups.	Baseline, 6 and 12 months	No
Secondary	Change in medications	Compare the experimental and control groups to determine if medication use has changed over the course of the study.	Baseline, 3, 6, 9, and 12 months	No
Secondary	Change in lipid profile	Compare the control and experimental groups to determine differences in lipid profile over time.	baseline, 3, 6, 9, and 12 months	No
Secondary	Hemoglobin A1c	Determine the difference in quarterly A1c measurements between the experimental and control groups over the course of the study.	baseline, 3, 6, 9, and 12 months	No