Type 2 DiabetesNCT01729117
A Trial of Meal Replacement at a Community Diabetes Clinic Serving a Low Socioeconomic Hispanic Population
A study testing Meal Replacement in people with Type 2 Diabetes and Obesity, run by University of Southern California at 1 site in United States.
Trial summary
Background and Rationale Research studies have shown that patients with type 2 diabetes (T2DM) who lose weight have better glucose control and less risk for heart disease. It has been difficult to achieve these results in a non-research setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- Meal Replacement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Apr 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Demographic
- Age >18 years
- Enrolled in the Roybal Diabetes Management Clinic
- Self-described as Hispanic
- Willing and able to participate in Spanish language group sessions.
- Willing and able to attend study visits for the duration of the study at the allocated times.
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- Willing and able to maintain a food exercise and medication log and perform and record self-monitoring of blood glucose (SMBG) Clinical
- T2DM diagnosed by fasting blood glucose >126mg/dL or random blood glucose >200mg/dL
- BMI>30 kg/m2
- If a woman of childbearing potential, using effective contraception. Biochemical HbA1c 8%-12% Medication
- On insulin therapy
Who cannot join
- Medical conditions
- Type 1 DM
- Illness likely to lead to unstable weight or altered glucose control.
- Proliferative diabetic retinopathy on eye examination within the last 6 months.
- Gallstones suspected on clinical history or documented on ultrasound.
- Serum creatinine >1.5mg/dL
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- Symptomatic cardiovascular disease
- Documented liver disease other than fatty liver
- Lactating, pregnant or intending to become pregnant within the following year Psycho-social conditions
- Inability or unwillingness to participate in a Spanish-language lifestyle group.
- Eating disorder such as bulimia
- Uncontrolled psychiatric disorder such as severe uncontrolled depression or bipolar disorder.
- Inability to attend scheduled appointments regularly for the duration of the study Medication use
- Use of weight loss medication within previous 3 months including exenatide.
- Use of medication (other than diabetes medication) likely to lead to unstable weight or altered glucose control
- Laxative or substance abuse
- More than 10 alcoholic drinks/week
Trial locations and contacts
1 site in 1 country.
United States1 site
Roybal Diabetes Management Clinic
Los Angeles, California, 90022
About this study
Official title: The 1,2,3 Plan: A Randomized Controlled Trial of Meal Replacement With a Lifestyle Modification Program vs. Standard Care at a Community Diabetes Clinic Serving a Low Socioeconomic Hispanic Population
Background and Rationale Research studies have shown that patients with type 2 diabetes (T2DM) who lose weight have better glucose control and less risk for heart disease. It has been difficult to achieve these results in a non-research setting. Meal replacements (MR) are pre-packaged meals with appropriate calories and nutrients that enhance adherence to a weight loss program by reducing decision-making and facilitating target caloric intake. The University of Southern California (USC) arm of the NIH funded Look AHEAD study at Roybal Clinic has demonstrated acceptability and success of MRs in conjunction with a structured lifestyle modification program in achieving weight loss in underserved Hispanic T2DM patients.
Objectives Our short-term objective is to determine the efficacy, safety and feasibility of a 3-month full MR program in conjunction with a 1 year standardized lifestyle modification program in a clinic setting. Our longer-term goal is to acquire data for sample size and power estimates for a larger NIH- or other funded prospective, randomized trial.
Read more
Study Methodology A 1-year, prospective trial study of 30 obese subjects with T2DM treated with insulin randomized to 2 groups: standard care (SC) or Meal Replacement group (MR). The SC will receive usual care at Roybal Diabetes Management Clinic (DMC). The MR will receive MRs and a lifestyle course in addition to the usual clinical care at the Roybal DMC. Phase 1 consists of 3-months 1200 -1400cal diet using full MR. Phase 2 consists of a 3-month transition to the same caloric intake using regular meals and 1 MR/day . Phase 3 consists of a 6-month weight loss maintenance period with 1 MR/day. This will be about 1400-1600 calories/day for women and 1800 to 2000 calories/day for men. Individual and group educational, support and counseling visits will be components of all 3 phases of the study.
Outcomes Efficacy of the program will be determined by weight, waist measurement and waist to hip ratio, blood pressure, HbA1c, lipids, and medication use at baseline and at 3, 6, 9 and 12 months. These are all measurements that are done routinely in these patients. Safety will be determined by monitoring of adverse events.
Data Analysis We will compare the outcomes between the SC and MR at 0,3,6,9 and 12 months to determine if there is evidence that the intervention improves outcomes and is safe.
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- Meal Replacement, Standard Care
- Keywords
- Type 2 diabetes, Obesity, Insulin, Hispanic, Low-income, Meal replacement
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal ReplacementOther
Also called HMR70 Plus products; HMR Boston, Massachusetts
5 Meal Replacements/day will be given for 3 months and then 1/day for 9 months.
Standard CareOther
Standard Care only
| Study group | Role | What they receive |
|---|---|---|
| Meal Replacement | Other | Meal Replacements will be provided to participants randomized to the MR group Receives: Other: Meal Replacement |
| Standard Care | Other | Standard Care participants will receive standard care but no meal replacements Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI
Measured: 12months
Secondary outcomes (1)
Severe Hypoglycemic Events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startMay 2009
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth O Beale, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729117
- Sponsor's protocol ID
- HS-08-00646
- Status last verified
- Nov 2012
- First submitted
- 13 Nov 2012
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 1,2,3 Plan: A Randomized Controlled Trial of Meal Replacement With a Lifestyle Modification Program vs. Standard Care at a Community Diabetes Clinic Serving a Low Socioeconomic Hispanic Population
- ClinicalTrials.gov ID
- NCT01729117
- Acronym / sponsor ID
- HS-08-00646
- Conditions
- Type 2 Diabetes, Obesity
- Keywords
- Type 2 diabetes, Obesity, Insulin, Hispanic, Low-income, Meal replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 20 Nov 2012 (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.
Background and Rationale Research studies have shown that patients with type 2 diabetes (T2DM) who lose weight have better glucose control and less risk for heart disease. It has been difficult to achieve these results in a non-research setting. Meal replacements (MR) are pre-packaged meals with appropriate calories and nutrients that enhance adherence to a weight loss program by reducing decision-making and facilitating target caloric intake. The University of Southern California (USC) arm of the NIH funded Look AHEAD study at Roybal Clinic has demonstrated acceptability and success of MRs in conjunction with a structured lifestyle modification program in achieving weight loss in underserved Hispanic T2DM patients.
Objectives Our short-term objective is to determine the efficacy, safety and feasibility of a 3-month full MR program in conjunction with a 1 year standardized lifestyle modification program in a clinic setting. Our longer-term goal is to acquire data for sample size and power estimates for a larger NIH- or other funded prospective, randomized trial.
Study Methodology A 1-year, prospective trial study of 30 obese subjects with T2DM treated with insulin randomized to 2 groups: standard care (SC) or Meal Replacement group (MR). The SC will receive usual care at Roybal Diabetes Management Clinic (DMC). The MR will receive MRs and a lifestyle course in addition to the usual clinical care at the Roybal DMC. Phase 1 consists of 3-months 1200 -1400cal diet using full MR. Phase 2 consists of a 3-month transition to the same caloric intake using regular meals and 1 MR/day . Phase 3 consists of a 6-month weight loss maintenance period with 1 MR/day. This will be about 1400-1600 calories/day for women and 1800 to 2000 calories/day for men. Individual and group educational, support and counseling visits will be components of all 3 phases of the study.
Outcomes Efficacy of the program will be determined by weight, waist measurement and waist to hip ratio, blood pressure, HbA1c, lipids, and medication use at baseline and at 3, 6, 9 and 12 months. These are all measurements that are done routinely in these patients. Safety will be determined by monitoring of adverse events.
Data Analysis We will compare the outcomes between the SC and MR at 0,3,6,9 and 12 months to determine if there is evidence that the intervention improves outcomes and is safe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meal Replacement | Other | Other: Meal ReplacementMeal Replacements will be provided to participants randomized to the MR group |
| Standard Care | Other | Other: Standard CareStandard Care participants will receive standard care but no meal replacements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Demographic
- Age >18 years
- Enrolled in the Roybal Diabetes Management Clinic
- Self-described as Hispanic
- Willing and able to participate in Spanish language group sessions.
Key exclusion criteria (17 listed)
- Medical conditions
- Type 1 DM
- Illness likely to lead to unstable weight or altered glucose control.
- Proliferative diabetic retinopathy on eye examination within the last 6 months.
- Gallstones suspected on clinical history or documented on ultrasound.
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 |
|---|---|---|
| Meal ReplacementAlso: HMR70 Plus products; HMR Boston, Massachusetts5 Meal Replacements/day will be given for 3 months and then 1/day for 9 months. | Other | Meal Replacement |
| Standard CareStandard Care only | Other | Standard Care |
Primary outcome
Change in BMI
Time frame: 12months
1 secondary outcome
Severe Hypoglycemic Events
Time frame: 12 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 20 Nov 2012.
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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.
Elizabeth O Beale, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal Replacement in people with Type 2 Diabetes and Obesity, run by University of Southern California 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 11 inclusion and 17 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 20 Nov 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.
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?
Change in BMI (time frame: 12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2012.