Diabetes Mellitus, Type 2D-CLIPNCT01283308
A Randomized Trial of Diabetes Prevention Through Lifestyle Change in India
A study testing Lifestyle Intervention in people with Diabetes Mellitus, Type 2, run by Emory University at 1 site in India.
Trial summary
People from the Indian subcontinent are more likely to get diabetes, even at younger ages. The Diabetes Community Lifestyle Improvement Program (D-CLIP) will test in a randomized trial if a culturally specific, community-based lifestyle and metformin (for individuals who do not respond to lifestyle change alone)… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 599 participants
- Where
- 1 siteIndia
- Study dates
- May 2009to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Live in or near Chennai, India
- Aged 20-65 years
- A BMI >22 kg/m2 and/or a waist circumference >90 cm for men and >80 cm for women
- No prior diabetes diagnosis, except for gestational diabetes
- At high risk of developing diabetes (pre-diabetes) as defined by a casual capillary glucose greater than or equal to 110 (measured during screening) AND Baseline fasting glucose of 100-125 mg/dL and/or 2-hour post-load glucose of 140-199 mg/dL
- Willingness to consent to randomization
Who cannot join
- Does not fulfill inclusion criteria
- Currently pregnant or breastfeeding
- History of or biomarkers indicating heart disease, serious illness, cancer diagnosis in the past 5 years, or other conditions that may impede or prohibit participation in an unsupervised diet change and physical activity program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Diabetes Community Lifestyle Improvement Program (D-CLIP): A Translation Randomized Trial of a Culturally Specific Lifestyle Intervention for Diabetes Prevention in India
People from the Indian subcontinent are more likely to get diabetes, even at younger ages. The Diabetes Community Lifestyle Improvement Program (D-CLIP) will test in a randomized trial if a culturally specific, community-based lifestyle and metformin (for individuals who do not respond to lifestyle change alone) intervention for men and women living in Chennai, India can effectively prevent type 2 diabetes in high-risk individuals. Lifestyle interventions are programs that seek to prevent disease by promoting changes in health behaviors, improved diet, increased physical activity, and weight loss. The results of this program will be used to make policy and public health recommendations, which will result in broader diabetes prevention efforts. The research team hypothesizes that this program will result in improvements in health (diabetes prevention, weight loss, and improvements in other markers of chronic disease) for intervention participants compared to participants in the control arm of the study.
Read the detailed description
Aims: The Diabetes Community Lifestyle Improvement Program (D-CLIP) aims to implement and evaluate in a controlled, randomized trial the effectiveness, cost-effectiveness, and sustainability of a culturally appropriate, low-cost, and sustainable lifestyle intervention for the prevention of type 2 diabetes mellitus in India.
Methods: D-CLIP, a translational research project adapted from the methods and curriculum developed and tested for efficacy in the Diabetes Prevention Program, utilizes innovated methods (a step-wise model of diabetes prevention with lifestyle and metformin added when needed; inclusion of individuals with isolated impaired glucose tolerance, isolated impaired fasting glucose, and both; classes team-taught by professionals and trained community educators) with the goals of increasing diabetes prevention, community acceptability, and long-term dissemination and sustainability of the program. The primary outcome is, diabetes incidence, and secondary outcomes are cost-effectiveness, changes in anthropometric measures, plasma lipids, blood pressure, blood glucose, and HbA1c, and program acceptability and sustainability assessed using a mixed methods approach.
Conclusion: D-CLIP, a low-cost, community-based, research program, addresses the key components of translational research and can be used as a model for prevention of chronic diseases in other low- and middle-income country settings.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Lifestyle Intervention, Standard of Care
- Keywords
- Diabetes Mellitus, Type 2, India, Prevention & Control, Lifestyle Intervention, Translational Research
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
Intervention arm participants will attend 6 months of weekly classes where they will be taught the skills necessary to reach these goals. The curriculum for the classes is based on the DPP lesson plans. Social support will be provided by trained lay health educators and peer support groups. Participants who remain at highest risk of T2DM after four or more months in the program will be prescribed metformin in addition to continuing the lifestyle program. Metformin dosages will start at 500 mg per day, and, when appropriate, will increase to 1000 mg per day (given as 500 mg twice per day). This group will be comprised of individuals who have (1) Fasting plasma glucose values of 100 mg/dl or more and (2) elevated fasting HbA1c measures of 5.7% or more.
Standard of CareBehavioural
Participants randomized to the standard of care group will meet with a physician and a dietician, attend one class/awareness lecture on diabetes prevention through weight loss and diet change and one class on exercise, and receive handouts reinforcing what they learn in class and with the dietician, fitness consultant, and physician.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Participants randomized to the standard of care group will receive standard lifestyle advice for diabetes prevention consistent with expert recommendations for a healthy lifestyle, including losing 5-10% of their excess body weight, following standard dietary recommendations to reduce calorie and fat intake, and exercising at least 150 minutes per week. Receives: Behavioral: Standard of Care |
| Lifestyle Intervention | Experimental | Intervention arm participants will participate in a step-wise model of diabetes prevention with the goal of reducing diabetes risk, primarily through (1) a weight loss of at least 7% and (2) 150 minutes or more per week of moderate level physical activity. Receives: Behavioral: Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Incidence
At baseline and follow-up visit(s), a 75-g oral glucose tolerance test will be administered to measure both 2-hour post-load glucose (2HG) and fasting plasma glucose (FPG). After the intervention and maintenance periods, blood glucose will be measured by a FPG test. Diabetes is diagnosed by a FPG≥126 mg/dL or a 2HG≥200 mg/dL. Diabetes incidence will be calculated by determining the proportion of individuals progressing from pre-diabetes to diabetes at each time point.
Measured: Baseline through end of follow-up (mean follow-up time = 3 years)
Secondary outcomes (10)
Body Weight
Weight will be measured in kilograms using a standardized, calibrated scale. Weight loss in kilograms and percent weight loss will be calculated.
Measured: Baseline through end of follow-up (mean follow-up time = 3 years)
Cost-effectiveness
The cost-effectiveness of the intensive lifestyle program, from the perspectives of a single payer system and society, will be compared with standard lifestyle advice by conducting incremental cost-effective analyses in which the net costs and net effectiveness of the intensive lifestyle program and the standard lifestyle advice is calculated and expressed as a ratio.
Measured: Baseline through end of follow-up (mean follow-up time = 3 years)
Waist circumference
Waist circumference in centimeters will be measured using a non-elastic tape measure. Change in waist circumference will be calculated.
Measured: Baseline through end of follow-up (mean follow-up time = 3 years)
Percent Body Fat
Percent body fat will be measured using bioelectrical impedance (Beurer machine).
Measured: Baseline through end of follow-up (mean follow-up time = 3 years)
Blood Pressure
Blood Pressure will be measured using standard procedures with an electronic BP apparatus.
Measured: Baseline through end of follow-up (mean follow-up time = 3 years)
Glycosylated hemoglobin (HbA1c)
HbA1c will be measured from a fasting venous blood sample.
Measured: Baseline through end of follow-up (mean follow-up time = 3 years)
Plasma Lipids
Plasma levels of high density lipoprotein (HDL), low density lipoprotein (LDL), triglycerides, and total cholesterol will be measured from fasting venous blood samples.
Measured: Baseline through end of follow-up (mean follow-up time = 3 years)
Beta Cell Function
Changes in beta cell function [as measured by the Oral Disposition Index, calculated as (ΔI0-30 /ΔG0-30) x (1/fasting insulin)] and insulin resistance (using the Homeostasis Model Assessment of Insulin Resistance, HOMA-IR) will be calculated.
Measured: Baseline through end of follow-up (mean follow-up time = 3 years)
Dietary Intake
Changes in average diet are assessed by comparing the results of a 12-month food frequency questionnaire (FFQ) from baseline to the end of the intervention period and during follow-up.
Measured: aseline through end of follow-up (mean follow-up time = 3 years)
Program Acceptability
The acceptability of the intervention will be assessed through focus group discussions with participants who received the lifestyle intervention and phone interviews with program drop-outs.
Measured: Baseline through end of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startMay 2009
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 599 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Madras Diabetes Research Foundation
- Responsible party
- Principal investigator, Venkat Narayan, Emory University
- Investigators
- Viswanathan Mohan, MD, PhD, Principal investigator, Madras Diabetes Research Foundation/Dr. Mohan's Diabetes Specialities CentreK.M. Venkat Narayan, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283308
- Sponsor's protocol ID
- IRB00016503
- Other IDs
- LT07-115
- Acronym
- D-CLIP
- Status last verified
- Oct 2016
- First submitted
- 24 Jan 2011
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Weber MB, Ranjani H, Anjana RM, Mohan V, Narayan KM, Gazmararian JA. Behavioral and psychosocial correlates of adiposity and healthy lifestyle in Asian Indians. Prim Care Diabetes. 2015 Dec;9(6):418-25. doi: 10.1016/j.pcd.2015.01.012. Epub 2015 Feb 26.
PubMed 25733342Staimez LR, Weber MB, Ranjani H, Ali MK, Echouffo-Tcheugui JB, Phillips LS, Mohan V, Narayan KM. Evidence of reduced beta-cell function in Asian Indians with mild dysglycemia. Diabetes Care. 2013 Sep;36(9):2772-8. doi: 10.2337/dc12-2290. Epub 2013 Apr 17.
PubMed 23596180Weber MB, Ranjani H, Meyers GC, Mohan V, Narayan KM. A model of translational research for diabetes prevention in low and middle-income countries: The Diabetes Community Lifestyle Improvement Program (D-CLIP) trial. Prim Care Diabetes. 2012 Apr;6(1):3-9. doi: 10.1016/j.pcd.2011.04.005. Epub 2011 May 26.
PubMed 21616737Ranjani H, Weber MB, Anjana RM, Lakshmi N, Narayan KMV, Mohan V. Recruitment challenges in a diabetes prevention trial in a low- and middle-income setting. Diabetes Res Clin Pract. 2015 Oct;110(1):51-59. doi: 10.1016/j.diabres.2015.07.013. Epub 2015 Aug 13.
PubMed 26321102Anjana RM, Ranjani H, Unnikrishnan R, Weber MB, Mohan V, Narayan KM. Exercise patterns and behaviour in Asian Indians: data from the baseline survey of the Diabetes Community Lifestyle Improvement Program (D-CLIP). Diabetes Res Clin Pract. 2015 Jan;107(1):77-84. doi: 10.1016/j.diabres.2014.09.053. Epub 2014 Oct 7.
PubMed 25458336Weber MB, Ranjani H, Staimez LR, Anjana RM, Ali MK, Narayan KM, Mohan V. The Stepwise Approach to Diabetes Prevention: Results From the D-CLIP Randomized Controlled Trial. Diabetes Care. 2016 Oct;39(10):1760-7. doi: 10.2337/dc16-1241. Epub 2016 Aug 8.
PubMed 27504014Pyo E, Weber MB, Sivaram J, Staimez LR, Mohan V, Anjana RM, Haardorfer R, Ranjani H. Construct validity of the 12-item Short Form Health Survey (SF-12) version 2 and the impact of lifestyle modifications on the health-related quality of life among Indian adults with prediabetes: results from the D-CLIP trial. Qual Life Res. 2024 Jun;33(6):1593-1603. doi: 10.1007/s11136-024-03648-6. Epub 2024 Apr 12.
PubMed 38607494Ford CN, Weber MB, Staimez LR, Anjana RM, Lakshmi K, Mohan V, Narayan KMV, Harish R. Dietary changes in a diabetes prevention intervention among people with prediabetes: the Diabetes Community Lifestyle Improvement Program trial. Acta Diabetol. 2019 Feb;56(2):197-209. doi: 10.1007/s00592-018-1249-1. Epub 2018 Nov 13.
PubMed 30426214Cioffi CE, Ranjani H, Staimez LR, Anjana RM, Mohan V, Weber MB. Self-efficacy and diabetes prevention in overweight South Asians with pre-diabetes. BMJ Open Diabetes Res Care. 2018 Oct 15;6(1):e000561. doi: 10.1136/bmjdrc-2018-000561. eCollection 2018.
PubMed 30397491
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diabetes Community Lifestyle Improvement Program (D-CLIP): A Translation Randomized Trial of a Culturally Specific Lifestyle Intervention for Diabetes Prevention in India
- ClinicalTrials.gov ID
- NCT01283308
- Acronym / sponsor ID
- D-CLIP / IRB00016503
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, India, Prevention & Control, Lifestyle Intervention, Translational Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 599 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Madras Diabetes Research Foundation
- Study start
- May 2009
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 25 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People from the Indian subcontinent are more likely to get diabetes, even at younger ages. The Diabetes Community Lifestyle Improvement Program (D-CLIP) will test in a randomized trial if a culturally specific, community-based lifestyle and metformin (for individuals who do not respond to lifestyle change alone) intervention for men and women living in Chennai, India can effectively prevent type 2 diabetes in high-risk individuals. Lifestyle interventions are programs that seek to prevent disease by promoting changes in health behaviors, improved diet, increased physical activity, and weight loss. The results of this program will be used to make policy and public health recommendations, which will result in broader diabetes prevention efforts. The research team hypothesizes that this program will result in improvements in health (diabetes prevention, weight loss, and improvements in other markers of chronic disease) for intervention participants compared to participants in the control arm of the study.
Detailed description
Aims: The Diabetes Community Lifestyle Improvement Program (D-CLIP) aims to implement and evaluate in a controlled, randomized trial the effectiveness, cost-effectiveness, and sustainability of a culturally appropriate, low-cost, and sustainable lifestyle intervention for the prevention of type 2 diabetes mellitus in India.
Methods: D-CLIP, a translational research project adapted from the methods and curriculum developed and tested for efficacy in the Diabetes Prevention Program, utilizes innovated methods (a step-wise model of diabetes prevention with lifestyle and metformin added when needed; inclusion of individuals with isolated impaired glucose tolerance, isolated impaired fasting glucose, and both; classes team-taught by professionals and trained community educators) with the goals of increasing diabetes prevention, community acceptability, and long-term dissemination and sustainability of the program. The primary outcome is, diabetes incidence, and secondary outcomes are cost-effectiveness, changes in anthropometric measures, plasma lipids, blood pressure, blood glucose, and HbA1c, and program acceptability and sustainability assessed using a mixed methods approach.
Conclusion: D-CLIP, a low-cost, community-based, research program, addresses the key components of translational research and can be used as a model for prevention of chronic diseases in other low- and middle-income country settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Behavioral: Standard of CareParticipants randomized to the standard of care group will receive standard lifestyle advice for diabetes prevention consistent with expert recommendations for a healthy lifestyle, including losing 5-10% of their excess body weight, following standard dietary recommendations to reduce calorie and fat intake, and exercising at least 150 minutes per week. |
| Lifestyle Intervention | Experimental | Behavioral: Lifestyle InterventionIntervention arm participants will participate in a step-wise model of diabetes prevention with the goal of reducing diabetes risk, primarily through (1) a weight loss of at least 7% and (2) 150 minutes or more per week of moderate level physical activity. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Live in or near Chennai, India
- Aged 20-65 years
- A BMI >22 kg/m2 and/or a waist circumference >90 cm for men and >80 cm for women
- No prior diabetes diagnosis, except for gestational diabetes
- At high risk of developing diabetes (pre-diabetes) as defined by a casual capillary glucose greater than or equal to 110 (measured during screening) AND Baseline fasting glucose of 100-125 mg/dL and/or 2-hour post-load glucose of 140-199 mg/dL
Key exclusion criteria (3 listed)
- Does not fulfill inclusion criteria
- Currently pregnant or breastfeeding
- History of or biomarkers indicating heart disease, serious illness, cancer diagnosis in the past 5 years, or other conditions that may impede or prohibit participation in an unsupervised diet change and physical activity program.
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 |
|---|---|---|
| Lifestyle InterventionIntervention arm participants will attend 6 months of weekly classes where they will be taught the skills necessary to reach these goals. The curriculum for the classes is based on the DPP lesson plans. Social support will be provided by trained lay health educators and peer support groups. Participants who remain at highest risk of T2DM after four or more months in the program will be prescribed metformin in addition to continuing the lifestyle program. Metformin dosages will start at 500 mg per day, and, when appropriate, will increase to 1000 mg per day (given as 500 mg twice per day). This group will be comprised of individuals who have (1) Fasting plasma glucose values of 100 mg/dl or more and (2) elevated fasting HbA1c measures of 5.7% or more. | Behavioural | Lifestyle Intervention |
| Standard of CareParticipants randomized to the standard of care group will meet with a physician and a dietician, attend one class/awareness lecture on diabetes prevention through weight loss and diet change and one class on exercise, and receive handouts reinforcing what they learn in class and with the dietician, fitness consultant, and physician. | Behavioural | Standard of Care |
Primary outcome
Diabetes Incidence
Time frame: Baseline through end of follow-up (mean follow-up time = 3 years)
At baseline and follow-up visit(s), a 75-g oral glucose tolerance test will be administered to measure both 2-hour post-load glucose (2HG) and fasting plasma glucose (FPG). After the intervention and maintenance periods, blood glucose will be measured by a FPG test. Diabetes is diagnosed by a FPG≥126 mg/dL or a 2HG≥200 mg/dL. Diabetes incidence will be calculated by determining the proportion of individuals progressing from pre-diabetes to diabetes at each time point.
10 secondary outcomes
Body Weight
Time frame: Baseline through end of follow-up (mean follow-up time = 3 years)
Cost-effectiveness
Time frame: Baseline through end of follow-up (mean follow-up time = 3 years)
Waist circumference
Time frame: Baseline through end of follow-up (mean follow-up time = 3 years)
Percent Body Fat
Time frame: Baseline through end of follow-up (mean follow-up time = 3 years)
Blood Pressure
Time frame: Baseline through end of follow-up (mean follow-up time = 3 years)
Glycosylated hemoglobin (HbA1c)
Time frame: Baseline through end of follow-up (mean follow-up time = 3 years)
Plasma Lipids
Time frame: Baseline through end of follow-up (mean follow-up time = 3 years)
Beta Cell Function
Time frame: Baseline through end of follow-up (mean follow-up time = 3 years)
Dietary Intake
Time frame: aseline through end of follow-up (mean follow-up time = 3 years)
Program Acceptability
Time frame: Baseline through end of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Background: PubMed 25733342Weber MB, Ranjani H, Anjana RM, Mohan V, Narayan KM, Gazmararian JA. Behavioral and psychosocial correlates of adiposity and healthy lifestyle in Asian Indians. Prim Care Diabetes. 2015 Dec;9(6):418-25. doi: 10.1016/j.pcd.2015.01.012. Epub 2015 Feb 26.
- Background: PubMed 23596180Staimez LR, Weber MB, Ranjani H, Ali MK, Echouffo-Tcheugui JB, Phillips LS, Mohan V, Narayan KM. Evidence of reduced beta-cell function in Asian Indians with mild dysglycemia. Diabetes Care. 2013 Sep;36(9):2772-8. doi: 10.2337/dc12-2290. Epub 2013 Apr 17.
- Background: PubMed 21616737Weber MB, Ranjani H, Meyers GC, Mohan V, Narayan KM. A model of translational research for diabetes prevention in low and middle-income countries: The Diabetes Community Lifestyle Improvement Program (D-CLIP) trial. Prim Care Diabetes. 2012 Apr;6(1):3-9. doi: 10.1016/j.pcd.2011.04.005. Epub 2011 May 26.
- Background: PubMed 26321102Ranjani H, Weber MB, Anjana RM, Lakshmi N, Narayan KMV, Mohan V. Recruitment challenges in a diabetes prevention trial in a low- and middle-income setting. Diabetes Res Clin Pract. 2015 Oct;110(1):51-59. doi: 10.1016/j.diabres.2015.07.013. Epub 2015 Aug 13.
- Background: PubMed 25458336Anjana RM, Ranjani H, Unnikrishnan R, Weber MB, Mohan V, Narayan KM. Exercise patterns and behaviour in Asian Indians: data from the baseline survey of the Diabetes Community Lifestyle Improvement Program (D-CLIP). Diabetes Res Clin Pract. 2015 Jan;107(1):77-84. doi: 10.1016/j.diabres.2014.09.053. Epub 2014 Oct 7.
- Results publication: PubMed 27504014Weber MB, Ranjani H, Staimez LR, Anjana RM, Ali MK, Narayan KM, Mohan V. The Stepwise Approach to Diabetes Prevention: Results From the D-CLIP Randomized Controlled Trial. Diabetes Care. 2016 Oct;39(10):1760-7. doi: 10.2337/dc16-1241. Epub 2016 Aug 8.
- Derived from this study: PubMed 38607494Pyo E, Weber MB, Sivaram J, Staimez LR, Mohan V, Anjana RM, Haardorfer R, Ranjani H. Construct validity of the 12-item Short Form Health Survey (SF-12) version 2 and the impact of lifestyle modifications on the health-related quality of life among Indian adults with prediabetes: results from the D-CLIP trial. Qual Life Res. 2024 Jun;33(6):1593-1603. doi: 10.1007/s11136-024-03648-6. Epub 2024 Apr 12.
- Derived from this study: PubMed 30426214Ford CN, Weber MB, Staimez LR, Anjana RM, Lakshmi K, Mohan V, Narayan KMV, Harish R. Dietary changes in a diabetes prevention intervention among people with prediabetes: the Diabetes Community Lifestyle Improvement Program trial. Acta Diabetol. 2019 Feb;56(2):197-209. doi: 10.1007/s00592-018-1249-1. Epub 2018 Nov 13.
- Derived from this study: PubMed 30397491Cioffi CE, Ranjani H, Staimez LR, Anjana RM, Mohan V, Weber MB. Self-efficacy and diabetes prevention in overweight South Asians with pre-diabetes. BMJ Open Diabetes Res Care. 2018 Oct 15;6(1):e000561. doi: 10.1136/bmjdrc-2018-000561. eCollection 2018.
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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.
Viswanathan Mohan, MD, PhD principal investigator
Madras Diabetes Research Foundation/Dr. Mohan's Diabetes Specialities Centre
K.M. Venkat Narayan, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention in people with Diabetes Mellitus, Type 2, run by Emory University at 1 site in India.
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 6 inclusion and 3 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 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diabetes Incidence (time frame: Baseline through end of follow-up (mean follow-up time = 3 years)). 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 NCT01283308, which also lists 9 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 31 Oct 2016.