Type2 DiabetesNCT03371940
Program ACTIVE II: Behavioral Depression Treatment for Type 2 Diabetes
A study testing Program ACTIVE Exercise, Program ACTIVE CBT and Program ACTIVE in people with Type2 Diabetes and Depression, run by Indiana University at 3 sites in United States.
Trial summary
Program ACTIVE II is a depression treatment study sponsored by the National Institutes of Health, Indiana University, Ohio University and West Virginia University. The purpose of this study is to test the effectiveness of two forms of treatment for depression for adults with type 2 diabetes: talk therapy (counseling)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type2 Diabetes, Depression
- What is being tested?
- Program ACTIVE Exercise, Program ACTIVE CBT and Program ACTIVE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jan 2012to 31 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- able to walk without the use of a cane or walker
- diagnosis of type 2 diabetes for at least one year duration or longer
- major depression lasting two weeks or longer
Who cannot join
- history of diabetic ketoacidosis (DKA)
- history of continuous insulin therapy since diabetes diagnosis
- stage 2 hypertension as defined by JNC VII
- recent cardiac events (e.g., unstable angina, diagnosed angina, PTCA, any cardiac intervention for CAD or tachydysrhythmias in the past six months)
- laser surgery for proliferative retinopathy in the past six months
- history of stroke, lower limb amputation, asensory peripheral neuropathy, aortic stenosis or other sever valvular heart disease, atrial fibrillation, severe COPD (e.g., basal oxygen), class III or IV heart failure
Show all 12Show fewer
- active suicidal ideation or history of suicide attempt
- history of bipolar disorder
- history of psychotic disorder
- current substance abuse or dependence disorder
- individuals who report the use of a current antidepressant medication for five weeks or less were excluded or deferred for later screening after the 6 week period
- individual who were receiving psychotherapy from a mental health provider for depression were excluded
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ohio University
Athens, Ohio, 45701
Indiana University
Indianapolis, Indiana, 46202
West Virginia University
Morgantown, West Virginia, 26506
About this study
Program ACTIVE II is a depression treatment study sponsored by the National Institutes of Health, Indiana University, Ohio University and West Virginia University. The purpose of this study is to test the effectiveness of two forms of treatment for depression for adults with type 2 diabetes: talk therapy (counseling) and exercise. Both of these forms of treatment have been proven to be effective in helping people with depression alone. In this study, the investigators will test to see if both of these approaches may be more effective in helping people live depression-free compared to talk therapy, exercise or usual care alone.
Read the detailed description
Program ACTIVE II is a study funded by the National Institute of Diabetes and Digestive and Kidney Diseases (R18DK092765) designed to test the combined effectiveness of two behavioral treatments for depression in people with type 2 diabetes: individual counseling (cognitive behavioral therapy; CBT) and exercise. While each of these treatment approaches has been tested individually in people with depression, no study has tested the combination of these approaches for people with major depression and type 2 diabetes. These approaches have the potential to work synergistically as a win-win strategy to improve both T2DM and depression outcomes while extending the reach of formal health care treatment strategies for diabetes.
Two primary study aims will be addressed by Program ACTIVE II: 1) to compare changes in glycemic control across intervention groups to UC at POST and 6- and 12-month follow-up assessments; and 2) to compare changes in MDD outcomes across intervention groups (i.e. CBT, EXER, CBT+EXER) to usual care (UC) following intervention (POST) and 6- and 12-month follow-up assessments.
The primary hypotheses are:
- Diabetes Outcomes. Based on the investigators' pilot data, mean glycemic control (as measured by HbA1c) is expected to improve .4% in participants in the EXER and CBT+EXER treatment conditions at POST compared to baseline [de Groot et al 2009]. Participants assigned to the CBT+EXER treatment are expected to show the greatest improvement in HbA1c followed by those in the EXER group in comparison to the CBT group. No improvement is expected among those assigned to the UC condition.
- Depression. Participants in the CBT, EXER and CBT+EXER conditions will show clinically significant improvements in BDI and diagnosis of MDD at POST and 6- and 12-month assessments with the greatest improvements expected among those in CBT+EXER condition. Based on pilot data, a) 66% reduction in the number of people who meet DSM-IV criteria for MDD is expected at POST compared to baseline; b) 86-90% percent of cases with MDD remission at POST are expected to remain remitted at the 6-month follow-up; c) severity of depression, as measured by the BDI-II, will significantly decrease from baseline to POST and baseline to follow-up assessments, after co-varying the effect of gender, number of T2DM complications, and exposure to treatment. It is anticipated that participants in the CBT+EXER condition will show the longest remission rates of depression followed by those in EXER and CBT. The secondary hypotheses are:
- Changes in CVD risk factors in the intervention groups compared to UC over time. Physical activity capacity, as measured by the 6-minute walk test (6MWT), will demonstrate the greatest improvements in the CBT+EXER arm, closely followed by the EXER arm at follow-up assessment compared to baseline. Participants in the CBT and UC arms are not expected to show significant improvements. LDL-C is expected to improve at POST in the EXER and CBT+EXER conditions consistent with pilot data.
- Cost Effectiveness Analyses. The predicted incidence of complications, particularly coronary heart disease (CHD), will be lower among those who receive CBT+EXER condition compared to the CBT, EXER and UC conditions. Further, the costs of this intensive intervention will be offset by a decrease in complication incidence.
- Conditions
- Type2 Diabetes, Depression
- Being tested
- Program ACTIVE Exercise, Program ACTIVE CBT, Program ACTIVE, Usual Care - No intervention
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program ACTIVE ExerciseBehavioural
Please see the Exercise arm description above.
Program ACTIVE CBTBehavioural
Please see the Talk Therapy arm description above.
Program ACTIVEBehavioural
Please see the Talk Therapy + Exercise arm description above.
Usual Care - No interventionBehavioural
Please see the Usual Care arm description above.
| Study group | Role | What they receive |
|---|---|---|
| Talk therapy (CBT) | Experimental | Participants randomized the talk therapy arm received 10 weeks of CBT or "talk therapy." The goal of CBT was to provide individuals with skills and concepts that they may use to: 1) manage and reduce depressive symptoms; 2) prevent the onset and severity of future depressive episodes; and 3) generalize these skills to diabetes management.
CBT interventionists facilitated patient management of depressive symptoms by providing participants with:
* Education about depression and the cognitive-behavioral therapy model;
* A safe relationship for participants to explore their symptom patterns and try to new tools to address them;
* Coaching as participants fully engage emotional and behavioral strategies. Receives: Behavioral: Program ACTIVE CBT |
| Exercise (EXER) | Experimental | Participants randomized to the exercise arm were enrolled in a 12-week physical activity intervention designed to increase aerobic physical activity. Participants were asked to complete 100 minutes of aerobic activity in Week 1, 125 minutes in Week 2, and 150 minutes per week of physical activity in Weeks 3-12. In addition, participants received 6 exercise training classes in which safe exercise practices were introduced and practiced, free access to a local exercise facility, use of a pedometer, completion of activity logs each week, and received an exercise workbook that addressed social and motivational aspects of physical activity. Receives: Behavioral: Program ACTIVE Exercise |
| Talk therapy + exercise (CBT+EXER) | Experimental | Participants randomized to the combination therapy received both talk therapy and exercise concurrently over a 12-week period as detailed above. Receives: Behavioral: Program ACTIVE |
| Usual care (UC) | Placebo comparator | Participants randomized to usual care received no study intervention. Receives: Behavioral: Usual Care - No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Based on our pilot data, mean glycemic control (as measured by HbA1c) is expected to improve .4% in participants in the EXER and CBT + EXER treatment conditions at POST (~3 month) compared to baseline (de Groot et al., 2009).
Measured: following completion of intervention (POST; ~3 months)
Change in Depression Status - Beck Depression Inventory
The BDI total score is a sum of 21 items (score range 0 - 63) with higher scores indicating greater depression symptomatology. We calculated change scores from baseline to POST (~3 months). Negative values indicate improvements in depression symptoms. Positive values indicate worsened depression symptoms.
Measured: following completion of intervention (POST; ~3 months)
Change in Depression Status - Diagnosis of Major Depressive Disorder
Data presented below is the proportion of participants in each treatment arm that achieved partial or full remission from MDD at POST (~3 months) intervention per the Structured Clinical Interview for the DSM-IV.
Measured: following completion of intervention (POST; ~3 months)
Secondary outcomes (1)
Physical Activity Capacity as Measured by the 6-minute Walk Test (6MWT)
Physical activity capacity as measured by the 6-minute walk test (6MWT, measured in feel walked)
Measured: following completion of intervention (POST; ~3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start1 Jan 2012
- Primary completion30 Jun 2016
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study subjects were randomly assigned to one of the four groups: talk therapy, exercise, talk therapy + exercise, or usual care. Separate randomization lists were generated by the study statistician for use by each of the three study sites.
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), West Virginia University, Ohio University, University of Michigan
- Responsible party
- Principal investigator, Mary de Groot, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371940
- Sponsor's protocol ID
- 1308973934
- Other IDs
- R18DK092765
- Status last verified
- May 2024
- First submitted
- 5 Dec 2017
- Last updated
- 28 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
de Groot M, Shubrook J, Schwartz F, Hornsby WG Jr, Pillay Y, Saha C. Program ACTIVE II: Design and Methods for a Multi-Center Community-Based Depression Treatment for Rural and Urban Adults with Type 2 Diabetes. J Diabetes Res Ther. 2015 Aug;1(2):10.16966/2380-5544.108. doi: 10.16966/2380-5544.108. Epub 2015 Aug 5.
PubMed 27500279de Groot M, Crick KA, Long M, Saha C, Shubrook JH. Lifetime Duration of Depressive Disorders in Patients With Type 2 Diabetes. Diabetes Care. 2016 Dec;39(12):2174-2181. doi: 10.2337/dc16-1145. Epub 2016 Oct 11.
PubMed 27729427de Groot M, Shubrook JH, Hornsby WG Jr, Pillay Y, Mather KJ, Fitzpatrick K, Yang Z, Saha C. Program ACTIVE II: Outcomes From a Randomized, Multistate Community-Based Depression Treatment for Rural and Urban Adults With Type 2 Diabetes. Diabetes Care. 2019 Jul;42(7):1185-1193. doi: 10.2337/dc18-2400. Epub 2019 May 21.
PubMed 31221693Kuo S, Ye W, de Groot M, Saha C, Shubrook JH, Hornsby WG Jr, Pillay Y, Mather KJ, Herman WH. Cost-effectiveness of Community-Based Depression Interventions for Rural and Urban Adults With Type 2 Diabetes: Projections From Program ACTIVE (Adults Coming Together to Increase Vital Exercise) II. Diabetes Care. 2021 Apr;44(4):874-882. doi: 10.2337/dc20-1639. Epub 2021 Feb 19.
PubMed 33608260Myers BA, Pillay Y, Guyton Hornsby W Jr, Shubrook J, Saha C, Mather KJ, Fitzpatrick K, de Groot M. Recruitment effort and costs from a multi-center randomized controlled trial for treating depression in type 2 diabetes. Trials. 2019 Nov 6;20(1):621. doi: 10.1186/s13063-019-3712-x.
PubMed 31694682
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program ACTIVE II: Behavioral Depression Treatment for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03371940
- Acronym / sponsor ID
- 1308973934
- Conditions
- Type2 Diabetes, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), West Virginia University, Ohio University, University of Michigan
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Posted 28 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Program ACTIVE II is a depression treatment study sponsored by the National Institutes of Health, Indiana University, Ohio University and West Virginia University. The purpose of this study is to test the effectiveness of two forms of treatment for depression for adults with type 2 diabetes: talk therapy (counseling) and exercise. Both of these forms of treatment have been proven to be effective in helping people with depression alone. In this study, the investigators will test to see if both of these approaches may be more effective in helping people live depression-free compared to talk therapy, exercise or usual care alone.
Detailed description
Program ACTIVE II is a study funded by the National Institute of Diabetes and Digestive and Kidney Diseases (R18DK092765) designed to test the combined effectiveness of two behavioral treatments for depression in people with type 2 diabetes: individual counseling (cognitive behavioral therapy; CBT) and exercise. While each of these treatment approaches has been tested individually in people with depression, no study has tested the combination of these approaches for people with major depression and type 2 diabetes. These approaches have the potential to work synergistically as a win-win strategy to improve both T2DM and depression outcomes while extending the reach of formal health care treatment strategies for diabetes.
Two primary study aims will be addressed by Program ACTIVE II: 1) to compare changes in glycemic control across intervention groups to UC at POST and 6- and 12-month follow-up assessments; and 2) to compare changes in MDD outcomes across intervention groups (i.e. CBT, EXER, CBT+EXER) to usual care (UC) following intervention (POST) and 6- and 12-month follow-up assessments.
The primary hypotheses are:
- Diabetes Outcomes. Based on the investigators' pilot data, mean glycemic control (as measured by HbA1c) is expected to improve .4% in participants in the EXER and CBT+EXER treatment conditions at POST compared to baseline [de Groot et al 2009]. Participants assigned to the CBT+EXER treatment are expected to show the greatest improvement in HbA1c followed by those in the EXER group in comparison to the CBT group. No improvement is expected among those assigned to the UC condition.
- Depression. Participants in the CBT, EXER and CBT+EXER conditions will show clinically significant improvements in BDI and diagnosis of MDD at POST and 6- and 12-month assessments with the greatest improvements expected among those in CBT+EXER condition. Based on pilot data, a) 66% reduction in the number of people who meet DSM-IV criteria for MDD is expected at POST compared to baseline; b) 86-90% percent of cases with MDD remission at POST are expected to remain remitted at the 6-month follow-up; c) severity of depression, as measured by the BDI-II, will significantly decrease from baseline to POST and baseline to follow-up assessments, after co-varying the effect of gender, number of T2DM complications, and exposure to treatment. It is anticipated that participants in the CBT+EXER condition will show the longest remission rates of depression followed by those in EXER and CBT. The secondary hypotheses are:
- Changes in CVD risk factors in the intervention groups compared to UC over time. Physical activity capacity, as measured by the 6-minute walk test (6MWT), will demonstrate the greatest improvements in the CBT+EXER arm, closely followed by the EXER arm at follow-up assessment compared to baseline. Participants in the CBT and UC arms are not expected to show significant improvements. LDL-C is expected to improve at POST in the EXER and CBT+EXER conditions consistent with pilot data.
- Cost Effectiveness Analyses. The predicted incidence of complications, particularly coronary heart disease (CHD), will be lower among those who receive CBT+EXER condition compared to the CBT, EXER and UC conditions. Further, the costs of this intensive intervention will be offset by a decrease in complication incidence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Study subjects were randomly assigned to one of the four groups: talk therapy, exercise, talk therapy + exercise, or usual care. Separate randomization lists were generated by the study statistician for use by each of the three study sites.
| Arm | Type | Receives |
|---|---|---|
| Talk therapy (CBT) | Experimental | Behavioral: Program ACTIVE CBTParticipants randomized the talk therapy arm received 10 weeks of CBT or "talk therapy." The goal of CBT was to provide individuals with skills and concepts that they may use to: 1) manage and reduce depressive symptoms; 2) prevent the onset and severity of future depressive episodes; and 3) generalize these skills to diabetes management. CBT interventionists facilitated patient management of depressive symptoms by providing participants with: * Education about depression and the cognitive-behavioral therapy model; * A safe relationship for participants to explore their symptom patterns and try to new tools to address them; * Coaching as participants fully engage emotional and behavioral strategies. |
| Exercise (EXER) | Experimental | Behavioral: Program ACTIVE ExerciseParticipants randomized to the exercise arm were enrolled in a 12-week physical activity intervention designed to increase aerobic physical activity. Participants were asked to complete 100 minutes of aerobic activity in Week 1, 125 minutes in Week 2, and 150 minutes per week of physical activity in Weeks 3-12. In addition, participants received 6 exercise training classes in which safe exercise practices were introduced and practiced, free access to a local exercise facility, use of a pedometer, completion of activity logs each week, and received an exercise workbook that addressed social and motivational aspects of physical activity. |
| Talk therapy + exercise (CBT+EXER) | Experimental | Behavioral: Program ACTIVEParticipants randomized to the combination therapy received both talk therapy and exercise concurrently over a 12-week period as detailed above. |
| Usual care (UC) | Placebo comparator | Behavioral: Usual Care - No interventionParticipants randomized to usual care received no study intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- able to walk without the use of a cane or walker
- diagnosis of type 2 diabetes for at least one year duration or longer
- major depression lasting two weeks or longer
Key exclusion criteria (12 listed)
- history of diabetic ketoacidosis (DKA)
- history of continuous insulin therapy since diabetes diagnosis
- stage 2 hypertension as defined by JNC VII
- recent cardiac events (e.g., unstable angina, diagnosed angina, PTCA, any cardiac intervention for CAD or tachydysrhythmias in the past six months)
- laser surgery for proliferative retinopathy in the past six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Program ACTIVE ExercisePlease see the Exercise arm description above. | Behavioural | Exercise (EXER) |
| Program ACTIVE CBTPlease see the Talk Therapy arm description above. | Behavioural | Talk therapy (CBT) |
| Program ACTIVEPlease see the Talk Therapy + Exercise arm description above. | Behavioural | Talk therapy + exercise (CBT+EXER) |
| Usual Care - No interventionPlease see the Usual Care arm description above. | Behavioural | Usual care (UC) |
Primary outcome
Change in HbA1c
Time frame: following completion of intervention (POST; ~3 months)
Based on our pilot data, mean glycemic control (as measured by HbA1c) is expected to improve .4% in participants in the EXER and CBT + EXER treatment conditions at POST (~3 month) compared to baseline (de Groot et al., 2009).
Change in Depression Status - Beck Depression Inventory
Time frame: following completion of intervention (POST; ~3 months)
The BDI total score is a sum of 21 items (score range 0 - 63) with higher scores indicating greater depression symptomatology. We calculated change scores from baseline to POST (~3 months). Negative values indicate improvements in depression symptoms. Positive values indicate worsened depression symptoms.
Change in Depression Status - Diagnosis of Major Depressive Disorder
Time frame: following completion of intervention (POST; ~3 months)
Data presented below is the proportion of participants in each treatment arm that achieved partial or full remission from MDD at POST (~3 months) intervention per the Structured Clinical Interview for the DSM-IV.
1 secondary outcome
Physical Activity Capacity as Measured by the 6-minute Walk Test (6MWT)
Time frame: following completion of intervention (POST; ~3 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27500279de Groot M, Shubrook J, Schwartz F, Hornsby WG Jr, Pillay Y, Saha C. Program ACTIVE II: Design and Methods for a Multi-Center Community-Based Depression Treatment for Rural and Urban Adults with Type 2 Diabetes. J Diabetes Res Ther. 2015 Aug;1(2):10.16966/2380-5544.108. doi: 10.16966/2380-5544.108. Epub 2015 Aug 5.
- Background: PubMed 27729427de Groot M, Crick KA, Long M, Saha C, Shubrook JH. Lifetime Duration of Depressive Disorders in Patients With Type 2 Diabetes. Diabetes Care. 2016 Dec;39(12):2174-2181. doi: 10.2337/dc16-1145. Epub 2016 Oct 11.
- Results publication: PubMed 31221693de Groot M, Shubrook JH, Hornsby WG Jr, Pillay Y, Mather KJ, Fitzpatrick K, Yang Z, Saha C. Program ACTIVE II: Outcomes From a Randomized, Multistate Community-Based Depression Treatment for Rural and Urban Adults With Type 2 Diabetes. Diabetes Care. 2019 Jul;42(7):1185-1193. doi: 10.2337/dc18-2400. Epub 2019 May 21.
- Results publication: PubMed 33608260Kuo S, Ye W, de Groot M, Saha C, Shubrook JH, Hornsby WG Jr, Pillay Y, Mather KJ, Herman WH. Cost-effectiveness of Community-Based Depression Interventions for Rural and Urban Adults With Type 2 Diabetes: Projections From Program ACTIVE (Adults Coming Together to Increase Vital Exercise) II. Diabetes Care. 2021 Apr;44(4):874-882. doi: 10.2337/dc20-1639. Epub 2021 Feb 19.
- Derived from this study: PubMed 31694682Myers BA, Pillay Y, Guyton Hornsby W Jr, Shubrook J, Saha C, Mather KJ, Fitzpatrick K, de Groot M. Recruitment effort and costs from a multi-center randomized controlled trial for treating depression in type 2 diabetes. Trials. 2019 Nov 6;20(1):621. doi: 10.1186/s13063-019-3712-x.
- Individual participant dataSharing planned: Undecided
Related trials for Type2 Diabetes
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
Recruiting
Insulin-Mediated Glucose Uptake and Organ Perfusion Assessed by Total-Body PET During GIP and GLP-1 Infusion
Type 2 Diabetes, Healhty
RecruitingObservational study
Dietitian-Nutritionist vs. Day Hospital in the Metabolic Control of Patients With Type 2 Diabetes
Diabetes (DM)
RecruitingPhase 2
Study to Assess the Effects of ALN-ANG3 in Adult Participants With Diabetic Kidney Disease
Diabetic Kidney Disease (DKD)
RecruitingObservational study
AI-Driven Metabolic Cohort in Overweight/Obese Chinese Adults
Overweight and Obesity, Diabetes Mellitus, Type 2
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Program ACTIVE Exercise, Program ACTIVE CBT and Program ACTIVE in people with Type2 Diabetes and Depression, run by Indiana University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: following completion of intervention (POST; ~3 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03371940, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.