Diabetes PreventionDPPNCT00729079
Diabetes Prevention Program Pilot Study
A study testing DPP in people with Diabetes Prevention, run by University of Rochester at 2 sites in United States.
Trial summary
This pilot study is intended to demonstrate that we can actually deliver the Diabetes Prevention Program intervention well and to show that it is likely effective. We will use results from this pilot study to support our application to The National Institute of Health. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Prevention
- What is being tested?
- DPP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2008to Oct 2009
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >18 years
- BMI >24 kg/m2 (>22 kg/m2 among Asian Americans)
- IGT (2-h plasma glucose 140~199 mg/dl based on 75-g OGTT if available). The OGTT will not be required for inclusion, but the CMA practitioners may wish to recommend the OGTT for their patients.
- Elevated FPG (95~125 mg/dl*).
- HDL-triglyceride ration > 3.5.
Who cannot join
- Diabetes at baseline
- FPG >126 mg/dl*
- 2-h plasma glucose >200 mg/dl based on 75-g OGTT, if available. OGTT will not be required (see above note).
- Diabetes diagnosed by a physician and confirmed by other clinical data, other than during pregnancy.
- Ever used antidiabetic medication, other than during pregnancy
- Medical conditions likely to limit life span and/or increase risk of intervention
Show all 38Show fewer
- Cardiovascular disease
- Hospitalization for treatment of heart disease in past 6 months New York Heart Association Functional Class> 2
- Left bundle branch block or third degree AV block Aortic stenosis
- Systolic blood pressure> 180 mmHg or diastolic blood pressure> 105 mmHg
- Cancer requiring treatment in the past 5 years, unless the prognosis is considered good
- Renal disease (creatinine GFR < or = 30 ml/hr or > 2.0 mg/dl if GFR not available).
- Anemia (hematocrit <36% in men or <33% in women)
- Hepatitis (based on history or serum transaminase elevation)
- Other gastrointestinal disease (pancreatitis, acute inflammatory bowel disease)
- Recent or significant abdominal surgery
- Pulmonary disease with dependence on oxygen or daily use of bronchodilators
- Chronic infection (e.g., HIV, active tuberculosis)
- Conditions or behaviors likely to affect conduct of the trial
- Unable to communicate with clinic staff (e.g., read and speak English).
- Unwilling to accept treatment assignment by randomization
- Participation in another intervention research project that might interfere with DPP
- Weight loss of > 10% in past 6 months for any reason except postpartum weight loss
- Unable to walk 0.25 miles in 10 min
- Currently pregnant or within 3 months postpartum
- Currently nursing or within 6 weeks of having completed nursing
- Pregnancy anticipated during the course of the trial
- Unwilling to undergo pregnancy testing or report possible pregnancy promptly
- Unwilling to take adequate contraceptive measures, if potentially fertile
- Major psychiatric disorder, including severe active major depression, severe anxiety, schizophrenia, manic depression, bi-polar disorder
- Excessive alcohol intake, either acute or chronic
- Medications and medical conditions likely to confound the assessment for diabetes including:
- Niacin, in doses indicated for lowering serum triglycerides
- Glucocorticoids, systemic
- Other prescription weight-loss medications
- Active Thyroid disease, suboptimally treated as indicated by abnormal serum thyroid-stimulating hormone
- Other endocrine disorders (e.g., Cushing's syndrome, acromegaly)
- Fasting plasma triglyceride >600 mg/dl, despite treatment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinton Medical Associated
Rochester, New York, 14620
Therapeutic Lifestyle Changes
Rochester, New York, 14620
About this study
Official title: Virtual Translation of Diabetes Prevention to Primary Care: A Pilot Study
This pilot study is intended to demonstrate that we can actually deliver the Diabetes Prevention Program intervention well and to show that it is likely effective. We will use results from this pilot study to support our application to The National Institute of Health. NIH is asking for health care centers to show ways to provide this treatment at a reasonable cost. We propose to demonstrate successful and sustainable use DPP's lifestyle intervention in a primary care health care setting (University of Rochester Primary Care).
- Conditions
- Diabetes Prevention
- Being tested
- DPP
- Keywords
- Diabetes Prevention, Pre-Diabetes, Exercise, Fat Intake, Fasting blood sugar, tobacco cessation
- Medical subject headings
- Glucose Intolerance, Motor Activity, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPPBehavioural
- The primary outcome measure is weight loss with a goal of 7% of initial weight.
- Secondary outcomes are adherence to behavior changes:
- Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week
- Fat intake less than 25% and saturated fat less than 10%
- Fiber intake of at least 25 grams per day
- Fasting blood sugar < 100 mg/dL
- Absence of tobacco use
DPPBehavioural
- The primary outcome measure is weight loss with a goal of 7% of initial weight.
- Secondary outcomes are adherence to behavior changes:
- Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week
- Fat intake less than 25% and saturated fat less than 10%
- Fiber intake of at least 25 grams per day
- Fasting blood sugar < 100 mg/dL
- Absence of tobacco use
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Subject will be randomly assigned to work with providers at Clinton Medical Associates Receives: Behavioral: DPP |
| 2 | Active comparator | Subjects will be randomly assigned to work with providers at 1655 Elmwood AVe, Suite 125 Receives: Behavioral: DPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is weight loss with a goal of 7% of initial weight.
Measured: 6 months
Secondary outcomes (2)
Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week
Measured: 6 months
;Fat intake less than 25% and saturated fat less than 10% Fiber intake of at least 25 grams per day;Fasting blood sugar < 100 mg/dL; Absence of tobacco use
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2008 (estimated)
- Study startDec 2008
- Primary completionJul 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diabetes PreventionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geoffrey Williams, University of Rochester
- Investigators
- Geoffrey C Williams, MD, PhD, Principal investigator, University ofRochesterHeather Patrick, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729079
- Sponsor's protocol ID
- 24895
- Acronym
- DPP
- Status last verified
- Mar 2013
- First submitted
- 1 Aug 2008
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
American Diabetes Association. Standards of medical care in diabetes--2008. Diabetes Care. 2008 Jan;31 Suppl 1:S12-54. doi: 10.2337/dc08-S012. No abstract available.
PubMed 18165335Benjamin SM, Valdez R, Geiss LS, Rolka DB, Narayan KM. Estimated number of adults with prediabetes in the US in 2000: opportunities for prevention. Diabetes Care. 2003 Mar;26(3):645-9. doi: 10.2337/diacare.26.3.645.
PubMed 12610015Goldstein MG, Whitlock EP, DePue J; Planning Committee of the Addressing Multiple Behavioral Risk Factors in Primary Care Project. Multiple behavioral risk factor interventions in primary care. Summary of research evidence. Am J Prev Med. 2004 Aug;27(2 Suppl):61-79. doi: 10.1016/j.amepre.2004.04.023.
PubMed 15275675Herman WH, Hoerger TJ, Brandle M, Hicks K, Sorensen S, Zhang P, Hamman RF, Ackermann RT, Engelgau MM, Ratner RE; Diabetes Prevention Program Research Group. The cost-effectiveness of lifestyle modification or metformin in preventing type 2 diabetes in adults with impaired glucose tolerance. Ann Intern Med. 2005 Mar 1;142(5):323-32. doi: 10.7326/0003-4819-142-5-200503010-00007.
PubMed 15738451Maciosek MV, Edwards NM, Coffield AB, Flottemesch TJ, Nelson WW, Goodman MJ, Solberg LI. Priorities among effective clinical preventive services: methods. Am J Prev Med. 2006 Jul;31(1):90-6. doi: 10.1016/j.amepre.2006.03.011.
PubMed 16777547Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801.
PubMed 11333990Westfall JM, Mold J, Fagnan L. Practice-based research--"Blue Highways" on the NIH roadmap. JAMA. 2007 Jan 24;297(4):403-6. doi: 10.1001/jama.297.4.403. No abstract available.
PubMed 17244837Williams GC, Grow VM, Freedman ZR, Ryan RM, Deci EL. Motivational predictors of weight loss and weight-loss maintenance. J Pers Soc Psychol. 1996 Jan;70(1):115-26. doi: 10.1037//0022-3514.70.1.115.
PubMed 8558405
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Translation of Diabetes Prevention to Primary Care: A Pilot Study
- ClinicalTrials.gov ID
- NCT00729079
- Acronym / sponsor ID
- DPP / 24895
- Conditions
- Diabetes Prevention
- Keywords
- Diabetes Prevention, Pre-Diabetes, Exercise, Fat Intake, Fasting blood sugar, tobacco cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 6 Aug 2008 (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.
This pilot study is intended to demonstrate that we can actually deliver the Diabetes Prevention Program intervention well and to show that it is likely effective. We will use results from this pilot study to support our application to The National Institute of Health. NIH is asking for health care centers to show ways to provide this treatment at a reasonable cost. We propose to demonstrate successful and sustainable use DPP's lifestyle intervention in a primary care health care setting (University of Rochester Primary Care).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: DPPSubject will be randomly assigned to work with providers at Clinton Medical Associates |
| 2 | Active comparator | Behavioral: DPPSubjects will be randomly assigned to work with providers at 1655 Elmwood AVe, Suite 125 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 years
- BMI >24 kg/m2 (>22 kg/m2 among Asian Americans)
- IGT (2-h plasma glucose 140~199 mg/dl based on 75-g OGTT if available). The OGTT will not be required for inclusion, but the CMA practitioners may wish to recommend the OGTT for their patients.
- Elevated FPG (95~125 mg/dl*).
- HDL-triglyceride ration > 3.5.
Key exclusion criteria (38 listed)
- Diabetes at baseline
- FPG >126 mg/dl*
- 2-h plasma glucose >200 mg/dl based on 75-g OGTT, if available. OGTT will not be required (see above note).
- Diabetes diagnosed by a physician and confirmed by other clinical data, other than during pregnancy.
- Ever used antidiabetic medication, other than during pregnancy
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 |
|---|---|---|
| DPP1. The primary outcome measure is weight loss with a goal of 7% of initial weight. 2. Secondary outcomes are adherence to behavior changes: 1. Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week 2. Fat intake less than 25% and saturated fat less than 10% 3. Fiber intake of at least 25 grams per day 4. Fasting blood sugar < 100 mg/dL 5. Absence of tobacco use | Behavioural | 1 |
| DPP1. The primary outcome measure is weight loss with a goal of 7% of initial weight. 2. Secondary outcomes are adherence to behavior changes: 1. Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week 2. Fat intake less than 25% and saturated fat less than 10% 3. Fiber intake of at least 25 grams per day 4. Fasting blood sugar < 100 mg/dL 5. Absence of tobacco use | Behavioural | 2 |
Primary outcome
The primary outcome measure is weight loss with a goal of 7% of initial weight.
Time frame: 6 months
2 secondary outcomes
Exercising a minimum of 150 minutes per week at a moderate level to maintain an energy expenditure of 700 kcals per week
Time frame: 6 months
;Fat intake less than 25% and saturated fat less than 10% Fiber intake of at least 25 grams per day;Fasting blood sugar < 100 mg/dL; Absence of tobacco use
Time frame: 6 months
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 12 Oct 2015.
- Background: PubMed 18165335American Diabetes Association. Standards of medical care in diabetes--2008. Diabetes Care. 2008 Jan;31 Suppl 1:S12-54. doi: 10.2337/dc08-S012. No abstract available.
- Background: PubMed 12610015Benjamin SM, Valdez R, Geiss LS, Rolka DB, Narayan KM. Estimated number of adults with prediabetes in the US in 2000: opportunities for prevention. Diabetes Care. 2003 Mar;26(3):645-9. doi: 10.2337/diacare.26.3.645.
- Background: PubMed 15275675Goldstein MG, Whitlock EP, DePue J; Planning Committee of the Addressing Multiple Behavioral Risk Factors in Primary Care Project. Multiple behavioral risk factor interventions in primary care. Summary of research evidence. Am J Prev Med. 2004 Aug;27(2 Suppl):61-79. doi: 10.1016/j.amepre.2004.04.023.
- Background: PubMed 15738451Herman WH, Hoerger TJ, Brandle M, Hicks K, Sorensen S, Zhang P, Hamman RF, Ackermann RT, Engelgau MM, Ratner RE; Diabetes Prevention Program Research Group. The cost-effectiveness of lifestyle modification or metformin in preventing type 2 diabetes in adults with impaired glucose tolerance. Ann Intern Med. 2005 Mar 1;142(5):323-32. doi: 10.7326/0003-4819-142-5-200503010-00007.
- Background: PubMed 16777547Maciosek MV, Edwards NM, Coffield AB, Flottemesch TJ, Nelson WW, Goodman MJ, Solberg LI. Priorities among effective clinical preventive services: methods. Am J Prev Med. 2006 Jul;31(1):90-6. doi: 10.1016/j.amepre.2006.03.011.
- Background: PubMed 11333990Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801.
- Background: PubMed 17244837Westfall JM, Mold J, Fagnan L. Practice-based research--"Blue Highways" on the NIH roadmap. JAMA. 2007 Jan 24;297(4):403-6. doi: 10.1001/jama.297.4.403. No abstract available.
- Background: PubMed 8558405Williams GC, Grow VM, Freedman ZR, Ryan RM, Deci EL. Motivational predictors of weight loss and weight-loss maintenance. J Pers Soc Psychol. 1996 Jan;70(1):115-26. doi: 10.1037//0022-3514.70.1.115.
- Diabetes Prevention ProgramLink provided by the sponsor.
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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.
Geoffrey C Williams, MD, PhD principal investigator
University ofRochester
Heather Patrick, PhD principal investigator
University of Rochester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DPP in people with Diabetes Prevention, run by University of Rochester at 2 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 5 inclusion and 38 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 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
The primary outcome measure is weight loss with a goal of 7% of initial weight. (time frame: 6 months). 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 NCT00729079, which also lists 8 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 12 Oct 2015.