Depression, Diabetes
Conditions
Keywords
Diabetes, Depression, diabetes outcomes, quality of life
Brief summary
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.
Detailed description
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.
Interventions
DRUGsertraline
50 mg up to 100 mg daily for 6 months
DRUGPlacebo
50 mg up to 100 mg daily for 6 months
Sponsors
Charles Drew University of Medicine and Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1C (%) | Month 0 and month 6 | Change in HbA1C (%) at month 0 and month 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | 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. |
Countries
United States
Participant flow
Recruitment details
Patients were screened for depression using Whooley's two questions tool at a county diabetes clinic.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Comparator: Placebo Placebo: 50 mg up to 100 mg daily for 6 months | 44 |
| Active Comparator: Sertraline sertraline: 50 mg up to 100 mg daily for 6 months | 45 |
| Total | 89 |
Baseline characteristics
| Characteristic | Placebo Comparator: Placebo | Active Comparator: Sertraline | Total |
|---|---|---|---|
| Age, Continuous | 53 years STANDARD_DEVIATION 10 | 52 years STANDARD_DEVIATION 8 | 53 years STANDARD_DEVIATION 8 |
| Race/Ethnicity, Customized African American | 5 participants | 5 participants | 10 participants |
| Race/Ethnicity, Customized Hispanic | 39 participants | 39 participants | 78 participants |
| Region of Enrollment United States | 44 participants | 45 participants | 89 participants |
| Sex: Female, Male Female | 32 Participants | 33 Participants | 65 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 44 | 3 / 45 |
| serious Total, serious adverse events | 2 / 44 | 0 / 45 |
Outcome results
Primary
HbA1C (%)
Change in HbA1C (%) at month 0 and month 6
Time frame: Month 0 and month 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | HbA1C (%) | HbA1C (%) Month 0 | 9.7 Percentage of glycosylated hemoglobin | Standard Deviation 1.6 |
| Placebo | HbA1C (%) | HbA1C (%) Month 6 | 8.8 Percentage of glycosylated hemoglobin | Standard Deviation 1.9 |
| Sertraline | HbA1C (%) | HbA1C (%) Month 0 | 10.0 Percentage of glycosylated hemoglobin | Standard Deviation 1.8 |
| Sertraline | HbA1C (%) | HbA1C (%) Month 6 | 8.0 Percentage of glycosylated hemoglobin | Standard Deviation 1.4 |
Secondary
Quality of Life
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.
Time frame: Month 0 and month 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Quality of Life | Diabetes Severity at Month 6 | 5.0 units on a scale | Standard Deviation 2 |
| Placebo | Quality of Life | Anxiety and Worry at Month 6 | 61.9 units on a scale | Standard Deviation 22.1 |
| Placebo | Quality of Life | Social Burden at Month 0 | 63.7 units on a scale | Standard Deviation 25.2 |
| Placebo | Quality of Life | Overall Quality of Life at Month 0 | 3.0 units on a scale | Standard Deviation 2 |
| Placebo | Quality of Life | Social Burden at Month 6 | 50.4 units on a scale | Standard Deviation 23.8 |
| Placebo | Quality of Life | Diabetes Severity at Month 0 | 6.0 units on a scale | Standard Deviation 3 |
| Placebo | Quality of Life | Sexual Function at Month 0 | 66.6 units on a scale | Standard Deviation 32.4 |
| Placebo | Quality of Life | Diabetes Control at Month 6 | 55.7 units on a scale | Standard Deviation 17.7 |
| Placebo | Quality of Life | Sexual Function at Month 6 | 61.1 units on a scale | Standard Deviation 33.2 |
| Placebo | Quality of Life | Overall Quality of Life at month 6 | 4.0 units on a scale | Standard Deviation 2 |
| Placebo | Quality of Life | Energy and Mobility at Month 0 | 63.1 units on a scale | Standard Deviation 20.1 |
| Placebo | Quality of Life | Anxiety and Worry at Month 0 | 76.7 units on a scale | Standard Deviation 16.5 |
| Placebo | Quality of Life | Energy and Mobility at Month 6 | 49.7 units on a scale | Standard Deviation 22 |
| Placebo | Quality of Life | Diabetes Control at Month 0 | 66.7 units on a scale | Standard Deviation 18.6 |
| Sertraline | Quality of Life | Energy and Mobility at Month 6 | 44.6 units on a scale | Standard Deviation 21.1 |
| Sertraline | Quality of Life | Anxiety and Worry at Month 6 | 57.1 units on a scale | Standard Deviation 21.8 |
| Sertraline | Quality of Life | Overall Quality of Life at Month 0 | 3.5 units on a scale | Standard Deviation 3 |
| Sertraline | Quality of Life | Overall Quality of Life at month 6 | 5.0 units on a scale | Standard Deviation 3 |
| Sertraline | Quality of Life | Diabetes Severity at Month 0 | 6.0 units on a scale | Standard Deviation 3 |
| Sertraline | Quality of Life | Diabetes Severity at Month 6 | 5.0 units on a scale | Standard Deviation 2 |
| Sertraline | Quality of Life | Diabetes Control at Month 0 | 69.6 units on a scale | Standard Deviation 13.4 |
| Sertraline | Quality of Life | Diabetes Control at Month 6 | 49.8 units on a scale | Standard Deviation 22 |
| Sertraline | Quality of Life | Anxiety and Worry at Month 0 | 78.8 units on a scale | Standard Deviation 12.6 |
| Sertraline | Quality of Life | Social Burden at Month 0 | 68.2 units on a scale | Standard Deviation 17.3 |
| Sertraline | Quality of Life | Social Burden at Month 6 | 43.8 units on a scale | Standard Deviation 25.8 |
| Sertraline | Quality of Life | Sexual Function at Month 0 | 67.8 units on a scale | Standard Deviation 28.2 |
| Sertraline | Quality of Life | Sexual Function at Month 6 | 56.7 units on a scale | Standard Deviation 31.2 |
| Sertraline | Quality of Life | Energy and Mobility at Month 0 | 67.6 units on a scale | Standard Deviation 16.2 |