Low-GI Dietary EducationPhase 1/2DEEPNCT00473811
Diabetic Educational Eating Plan
A Phase 1/2 study testing Low GI and ADA diet in people with Low-GI Dietary Education and ADA Dietary Education, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
By improving glycemic control, many of the devastating complications of diabetes are to a large extent preventable. The use of a low GI (glycemic index) diet to improve glycemic control is relatively new and untested. However, a low GI diet may be a cost-effective approach to preventing diabetes-related complications. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Low-GI Dietary Education, ADA Dietary Education
- What is being tested?
- Low GI and ADA diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Aug 2012
- Phase
- Phase 1/2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type II diabetes in the medical chart
- HbA1c level >= 7 (an indication of poor control of diabetes)
- Currently being treated with diet, oral hypoglycemic agents and/or insulin
- At least 21 years old
- Telephone in home or easy access to one
- Able to understand study protocol
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- Understands and can provide informed consent
- Physician's approval to participate in study
- Has a blood glucose machine or a prescription for one from their physician
- Able to speak and read English
- Willing to be randomized to either of the two study groups
- Able to participate in the study for a one year length of time.
Who cannot join
- Pregnant or planning to become pregnant during the study
- Unable or unwilling to provide informed consent
- Plans to move out of the area within the 12-month study period
- Required intermittent glucocorticoid therapy within the past 3 months
- Documented acute coronary event (MI or unstable angina) within the past 6 months
- Diagnosis of a medical condition that precludes adherence to study dietary recommendations (e.g. Crohn's disease, ulcerative colitis, end-stage renal disease)
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- Diagnosis of a psychiatric illness (i.e. dementia, psychiatric hospitalization or suicidality within the past 5 years). We will not exclude individuals with a diagnosis of depression or patients taking anti-depressants.
- Following a low-carbohydrate high fat dietary regimen such as the Atkins diet, or currently following the South Beach Diet
- Legally blind or has significant visual impairments
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Applicability of a Low Glycemic Index Diet in Diabetes
By improving glycemic control, many of the devastating complications of diabetes are to a large extent preventable. The use of a low GI (glycemic index) diet to improve glycemic control is relatively new and untested. However, a low GI diet may be a cost-effective approach to preventing diabetes-related complications. The aim of this proposed 2-year study is to gather pilot data on the feasibility of implementing a nutritionist-delivered low GI intervention, to reduce dietary GI in patients with type 2 diabetes, and to compare it with a nutritionist-delivered standard American Diabetes Association (ADA) diet intervention. Our outcomes are recruitment and retention rates, as well as physiological measures (HbA1c, blood lipids, blood pressure, and body mass index), dietary GI scores and acceptability of the intervention.
Primary hypotheses:
Read more
- Recruitment and retention rates for the low GI intervention will be satisfactory.
Secondary hypotheses:
- Participants in the low GI intervention group will show more favorable changes in physiological measures than participants in the ADA diet group.
- Participants in the low GI group will be successful in lowering the GI of their diet.
- Participants will find the intervention acceptable.
Read the detailed description
The glycemic index (GI) is a ranking of carbohydrate containing foods according to the rate at which they raise blood glucose levels after eating. A recent meta-analysis of randomized clinical trials (RCT) suggests that choosing low GI foods has a small but clinically useful effect on medium-term glycemic control in patients with type 2 diabetes. However, in most of the reviewed RCTs, patients were fed experimental diets and therefore there is still controversy over the applicability of GI in the clinical setting for management of diabetes. In addition, there is no evidence that long-term consumption of a low GI diet will contribute to improved glycemic control in people with diabetes.
Our ultimate goal for a future larger RCT is to evaluate the long-term effects of using low GI diet in type 2 diabetics. The primary outcome variable of the future large trial will be glycosylated hemoglobin levels (HbA1c), a measure reflecting average glycemic level during the preceding 2-3 months. The proposed feasibility study will recruit 40 patients with type 2 diabetes and will randomly assign them to one of two groups: a low GI nutrition education group (low GI group) and a standard ADA dietary education group as the control group (ADA group) (20 patients in each group).
For both groups, the intervention phase will last 6 months and consist of an initial group session, an individual session, and then four group counseling sessions. The follow-up phase will be six months and consist of two group booster sessions, one at 8-months and another at 10-months. The low GI nutritional education will be primarily targeted at a low GI diet. The focus is not on decreasing total carbohydrate intake, but rather encouraging patients to substitute low GI foods for high GI foods. The dietary intervention will be based on a patient-centered counseling model which has been demonstrated to facilitate health behavior change. Data collection points coincide with two phases of the intervention. Assessments, including demographics, anthropometric measurements, diet and physical activity recalls, and clinical data, will be conducted at baseline, and at 6 and 12 months after randomization, with blood samples collected at each interval. We will track response to recruitment, adherence, and retention. Quantitative and qualitative methods will be used to assess acceptability of the intervention.
The aim of this proposed 2-year study is to gather pilot data on the feasibility of implementing a nutritionist-delivered low GI intervention to reduce dietary GI in patients with type 2 diabetes. Our outcomes are recruitment and retention rates, as well as physiological measures (HbA1c, blood pressure, and body mass index), dietary GI scores and acceptability of the intervention.
By improving glycemic control, many of the devastating complications of diabetes are to a large extent preventable. The use of a low GI diet to improve glycemic control is relatively new and untested. However, a low GI diet may be a cost-effective approach to preventing diabetes-related complications. Testing the feasibility of such a program and its potential impact would be an important step towards an RO1 application to the NIH.
- Conditions
- Low-GI Dietary Education, ADA Dietary Education
- Being tested
- Low GI, ADA diet
- Keywords
- Glycemic index, carbohydrates, diabetes mellitus, type 2, randomized clinical trial
- 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.
Low GIBehavioural
low-GI education
ADA dietBehavioural
ADA dietary education
| Study group | Role | What they receive |
|---|---|---|
| ADA diet | Active comparator | Patients will be encouarged to consume foods consisted with ADA dietary recommendation Receives: Behavioral: ADA diet |
| Low-GI | Experimental | a low GI dietary education Receives: Behavioral: Low GI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Our outcomes are recruitment and retention rates, as well as physiological measures (HbA1c, blood pressure, and body mass index), dietary GI scores and acceptability of the intervention
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2007 (estimated)
- Study startAug 2005
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low-GI Dietary EducationStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunsheng Ma, University of Massachusetts, Worcester
- Investigators
- Yunsheng Ma, MD, Ph.D., Principal investigator, Division of Preventive & Behavioral Medicine, Department of Medicine, University of Massachusetts Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473811
- Sponsor's protocol ID
- 5P30DK032520-24
- Acronym
- DEEP
- Status last verified
- Aug 2012
- First submitted
- 14 May 2007
- Last updated
- 30 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Ma Y, Olendzki BC, Hafner AR, Chiriboga DE, Culver AL, Andersen VA, Merriam PA, Pagoto SL. Low-carbohydrate and high-fat intake among adult patients with poorly controlled type 2 diabetes mellitus. Nutrition. 2006 Nov-Dec;22(11-12):1129-36. doi: 10.1016/j.nut.2006.08.006. Epub 2006 Oct 4.
PubMed 17027229Ma Y, Olendzki BC, Merriam PA, Chiriboga DE, Culver AL, Li W, Hebert JR, Ockene IS, Griffith JA, Pagoto SL. A randomized clinical trial comparing low-glycemic index versus ADA dietary education among individuals with type 2 diabetes. Nutrition. 2008 Jan;24(1):45-56. doi: 10.1016/j.nut.2007.10.008.
PubMed 18070658
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applicability of a Low Glycemic Index Diet in Diabetes
- ClinicalTrials.gov ID
- NCT00473811
- Acronym / sponsor ID
- DEEP / 5P30DK032520-24
- Conditions
- Low-GI Dietary Education, ADA Dietary Education
- Keywords
- Glycemic index, carbohydrates, diabetes mellitus, type 2, randomized clinical trial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 16 May 2007 (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.
By improving glycemic control, many of the devastating complications of diabetes are to a large extent preventable. The use of a low GI (glycemic index) diet to improve glycemic control is relatively new and untested. However, a low GI diet may be a cost-effective approach to preventing diabetes-related complications. The aim of this proposed 2-year study is to gather pilot data on the feasibility of implementing a nutritionist-delivered low GI intervention, to reduce dietary GI in patients with type 2 diabetes, and to compare it with a nutritionist-delivered standard American Diabetes Association (ADA) diet intervention. Our outcomes are recruitment and retention rates, as well as physiological measures (HbA1c, blood lipids, blood pressure, and body mass index), dietary GI scores and acceptability of the intervention.
Primary hypotheses:
- Recruitment and retention rates for the low GI intervention will be satisfactory.
Secondary hypotheses:
- Participants in the low GI intervention group will show more favorable changes in physiological measures than participants in the ADA diet group.
- Participants in the low GI group will be successful in lowering the GI of their diet.
- Participants will find the intervention acceptable.
Detailed description
The glycemic index (GI) is a ranking of carbohydrate containing foods according to the rate at which they raise blood glucose levels after eating. A recent meta-analysis of randomized clinical trials (RCT) suggests that choosing low GI foods has a small but clinically useful effect on medium-term glycemic control in patients with type 2 diabetes. However, in most of the reviewed RCTs, patients were fed experimental diets and therefore there is still controversy over the applicability of GI in the clinical setting for management of diabetes. In addition, there is no evidence that long-term consumption of a low GI diet will contribute to improved glycemic control in people with diabetes.
Our ultimate goal for a future larger RCT is to evaluate the long-term effects of using low GI diet in type 2 diabetics. The primary outcome variable of the future large trial will be glycosylated hemoglobin levels (HbA1c), a measure reflecting average glycemic level during the preceding 2-3 months. The proposed feasibility study will recruit 40 patients with type 2 diabetes and will randomly assign them to one of two groups: a low GI nutrition education group (low GI group) and a standard ADA dietary education group as the control group (ADA group) (20 patients in each group).
For both groups, the intervention phase will last 6 months and consist of an initial group session, an individual session, and then four group counseling sessions. The follow-up phase will be six months and consist of two group booster sessions, one at 8-months and another at 10-months. The low GI nutritional education will be primarily targeted at a low GI diet. The focus is not on decreasing total carbohydrate intake, but rather encouraging patients to substitute low GI foods for high GI foods. The dietary intervention will be based on a patient-centered counseling model which has been demonstrated to facilitate health behavior change. Data collection points coincide with two phases of the intervention. Assessments, including demographics, anthropometric measurements, diet and physical activity recalls, and clinical data, will be conducted at baseline, and at 6 and 12 months after randomization, with blood samples collected at each interval. We will track response to recruitment, adherence, and retention. Quantitative and qualitative methods will be used to assess acceptability of the intervention.
The aim of this proposed 2-year study is to gather pilot data on the feasibility of implementing a nutritionist-delivered low GI intervention to reduce dietary GI in patients with type 2 diabetes. Our outcomes are recruitment and retention rates, as well as physiological measures (HbA1c, blood pressure, and body mass index), dietary GI scores and acceptability of the intervention.
By improving glycemic control, many of the devastating complications of diabetes are to a large extent preventable. The use of a low GI diet to improve glycemic control is relatively new and untested. However, a low GI diet may be a cost-effective approach to preventing diabetes-related complications. Testing the feasibility of such a program and its potential impact would be an important step towards an RO1 application to the NIH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADA diet | Active comparator | Behavioral: ADA dietPatients will be encouarged to consume foods consisted with ADA dietary recommendation |
| Low-GI | Experimental | Behavioral: Low GIa low GI dietary education |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis of type II diabetes in the medical chart
- HbA1c level >= 7 (an indication of poor control of diabetes)
- Currently being treated with diet, oral hypoglycemic agents and/or insulin
- At least 21 years old
- Telephone in home or easy access to one
Key exclusion criteria (9 listed)
- Pregnant or planning to become pregnant during the study
- Unable or unwilling to provide informed consent
- Plans to move out of the area within the 12-month study period
- Required intermittent glucocorticoid therapy within the past 3 months
- Documented acute coronary event (MI or unstable angina) within the past 6 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 |
|---|---|---|
| Low GIlow-GI education | Behavioural | Low-GI |
| ADA dietADA dietary education | Behavioural | ADA diet |
Primary outcome
Our outcomes are recruitment and retention rates, as well as physiological measures (HbA1c, blood pressure, and body mass index), dietary GI scores and acceptability of the intervention
Time frame: one year
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 30 Aug 2012.
- Results publication: PubMed 17027229Ma Y, Olendzki BC, Hafner AR, Chiriboga DE, Culver AL, Andersen VA, Merriam PA, Pagoto SL. Low-carbohydrate and high-fat intake among adult patients with poorly controlled type 2 diabetes mellitus. Nutrition. 2006 Nov-Dec;22(11-12):1129-36. doi: 10.1016/j.nut.2006.08.006. Epub 2006 Oct 4.
- Results publication: PubMed 18070658Ma Y, Olendzki BC, Merriam PA, Chiriboga DE, Culver AL, Li W, Hebert JR, Ockene IS, Griffith JA, Pagoto SL. A randomized clinical trial comparing low-glycemic index versus ADA dietary education among individuals with type 2 diabetes. Nutrition. 2008 Jan;24(1):45-56. doi: 10.1016/j.nut.2007.10.008.
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.
Yunsheng Ma, MD, Ph.D. principal investigator
Division of Preventive & Behavioral Medicine, Department of Medicine, University of Massachusetts Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Low GI and ADA diet in people with Low-GI Dietary Education and ADA Dietary Education, run by University of Massachusetts, Worcester at 1 site 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 12 inclusion and 9 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 30 Aug 2012. 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 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Our outcomes are recruitment and retention rates, as well as physiological measures (HbA1c, blood pressure, and body mass index), dietary GI scores and acceptability of the intervention (time frame: one year). 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 NCT00473811, which also lists 2 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 30 Aug 2012.