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Treatment of Diabetes and Depression in Hispanics and African Americans and Its Effect on A1c and Quality of Life.

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ClinicalTrials.gov Identifier: NCT00624013
Recruitment Status : Completed
First Posted : February 26, 2008
Results First Posted : December 12, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):

February 15, 2008
February 26, 2008
April 13, 2017
December 12, 2017
December 12, 2017
September 2006
October 2008   (Final data collection date for primary outcome measure)
HbA1C (%) [ Time Frame: Month 0 and month 6 ]
Change in HbA1C (%) at month 0 and month 6
A1c [ Time Frame: 0, 2, 4 6, 12 months ]
Complete list of historical versions of study NCT00624013 on ClinicalTrials.gov Archive Site
Quality of Life [ Time Frame: Month 0 and month 6 ]
Quality of life (QOL) was assed at baseline and at month 6 using validated instrument Diabetes-39 Quality of Life Questionnaire. It consists of 39-item questionnaire designed to help us learn more about what affects the quality of life of people with diabetes in five dimensions of patients' lives: Diabetes Control, Anxiety and Worry, Social Burden, Sexual Functioning and Energy and Mobility. The Diabetes-39 questionnaire uses a Not Affected At All -Extremely Affected point scale score ranging from 1-7. Raw scale scores were transformed to a 0-100 scale using a linear transformation. Higher values represent a worse outcome. Overall rating of Quality-of-Life was assessed using a Lowest quality-Highest quality scale ranging from 1-7. Higher values represent an increase or improvement in overall QOL. Pattern of Diabetes Severity was measured with a Not Severe at all-Extremely Severe scale ranging from 1-7. Higher values represent increase in diabetes severity.
Quality of Life [ Time Frame: 0, 6, 12 months ]
Not Provided
Not Provided
 
Treatment of Diabetes and Depression in Hispanics and African Americans and Its Effect on A1c and Quality of Life.
Effect of Pharmacological Treatment of Depression on A1C and Quality of Life in Underserved Hispanics and African Americans With Diabetes: A Randomized, Placebo Controlled Trial.
This proposed study will test the following hypothesis: Treating depression in Hispanics and African Americans with diabetes will improve their HbA1c and quality of life while on intervention and six months after intervention.

The medication to be used will be sertraline (Zoloft). Sertraline (Zoloft)has been proven in clinical trials to be an effective and well tolerated prescription medication that improves the quality and enjoyment of life for adults suffering from depression . Sertraline is an antidepressant and a member of the family of medications known as selective serotonin reuptake inhibitors (SSRIs). It has excellent tolerability and minimal drug-drug intereactions.

The hypothesis will be tested by the following specific aims:

  1. To determine if treating mild to moderate depression with sertraline (Zoloft) in patients with diabetes improves HbA1c.
  2. To determine if treating mild to moderate depression with sertraline (Zoloft) in patients with diabetes improves quality of life.

If our hypothesis proves correct and this treatment of depression is efficient and easy in a county hospital population of African Americans and Hispanics, researchers can move forward in finding fast and efficient means of diagnosing depression in vulnerable populations, including low-literate patients. This study is critical in that it stands to improve the HBA1c (and other metabolic parameters) and quality of life of our underserved minority community, which sadly suffers from a higher rate of almost every disease, including diabetes. Treating mild to moderate depression in a county hospital population of African Americans and Hispanics may improve quality of life and reduce/prevent complications and early death. Secondary outcomes include reduced hospitalizations, fewer missed appointments, and improved adherence to medication.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetes
  • Depression
  • Drug: sertraline
    50 mg up to 100 mg daily for 6 months
    Other Name: Zoloft
  • Drug: Placebo
    50 mg up to 100 mg daily for 6 months
  • Placebo Comparator: Placebo
    Placebo 50 mg up to 100 mg daily for 6 months
    Intervention: Drug: Placebo
  • Active Comparator: Sertraline (Zoloft)
    Sertraline (Zoloft) 50 mg up to 100 mg daily for 6 months
    Intervention: Drug: sertraline
Echeverry D, Duran P, Bonds C, Lee M, Davidson MB. Effect of pharmacological treatment of depression on A1C and quality of life in low-income Hispanics and African Americans with diabetes: a randomized, double-blind, placebo-controlled trial. Diabetes Care. 2009 Dec;32(12):2156-60. doi: 10.2337/dc09-0785. Epub 2009 Sep 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
October 2008
October 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients (men, women) who are African American or Hispanic over the age of 21 who have been diagnosed with type 2 diabetes and have a HbA1c of greater than 8.0%. Subjects with neuropathic pain will be included in the study. Their pain will be assessed via a validated pain scale. Their primary care providers will treat their pain as necessary.

Exclusion Criteria:

  • Pregnant women, patients on dialysis, patients with liver disease or liver enzymes elevated three times above normal, patients with blood pressure greater than 160 systolic or 95 diastolic on two consecutive visits, patients with history of severe depression (as determined by hospitalization or the HAM-D survey) or suicide attempts, patients on therapy for depression, patients already taking SSRI's, and patients with psychotic features or bipolar disease.
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00624013
5 U54 RR01616-07
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Plan to Share IPD: No
Mayer Davidson, Charles Drew University of Medicine and Science
Charles Drew University of Medicine and Science
Not Provided
Study Director: Mayer Davidson, M.D. Charles Drew University School of Medicine
Charles Drew University of Medicine and Science
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP