Type 2 Diabetes MellitusNCT00907075
Pilot Study to Assess Adherence to a Novel Eating System in Men and Women With Type 2 Diabetes Mellitus
A study testing NES With Energy Restriction and NES Without Energy Restriction in people with Type 2 Diabetes Mellitus, run by Mondelēz International, Inc. at 2 sites in United States.
Trial summary
The purpose of this pilot study is to assess adherence to a Novel Eating System (NES) with and without energy restriction. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- NES With Energy Restriction and NES Without Energy Restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2009to Sep 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18-79 years of age, inclusive.
- Diagnosis of type 2 diabetes, at least nine months prior to screening.
- Stable use of oral hypoglycemic medication for at least two months prior to screening.
- Body mass index (BMI) ≥25.0 and <45.0 kg/m2 at screening.
- Willingness to follow a novel eating plan, which may be energy restricted to promote weight loss, throughout the trial.
Who cannot join
- History or diagnosis of type 1 diabetes mellitus.
- Poorly controlled type 2 diabetes mellitus (HbA1C ≥9.0%).
- Weight loss or gain >10 lb (4.5 kg) in the two months prior to screening.
- Abnormal laboratory test results of clinical importance.
- History of gastrointestinal surgery for weight-reducing purposes.
- Poorly controlled hypertension.
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- A clinically important medical or other condition.
- Any major trauma or major surgical event within three months of screening.
- Use of injected medications for glucose control within four weeks prior to screening.
- Use of weight loss medications, supplements, programs, or meal replacement products within two months of screening.
- Unstable use of foods, dietary supplements, herbals or medications, other than allowed medications, that have the potential to influence carbohydrate or lipid metabolism.
- Pregnancy
- Any history of extreme eating habits or an eating disorder diagnosed by a health professional.
- Recent history of (within 12 months of visit 1) or strong potential for alcohol or substance abuse.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Provident Clinical Research & Consulting, Inc.
Addison, Illinois, 60101
Provident Clinical Research & Consulting, Inc.
Bloomington, Indiana, 47403
About this study
The purpose of this pilot study is to assess adherence to a Novel Eating System (NES) with and without energy restriction.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- NES With Energy Restriction, NES Without Energy Restriction
- Keywords
- diabetes, nutrition, diet, foods
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NES With Energy RestrictionBehavioural
The NES will be administered based upon the individual's calculated daily energy requirement, with an energy deficit of approximately 500 kilocalories.
NES Without Energy RestrictionBehavioural
The NES will be administered based upon the individual's calculated daily energy requirement.
| Study group | Role | What they receive |
|---|---|---|
| NES With Energy Restriction | Active comparator | Not described Receives: Behavioral: NES With Energy Restriction |
| NES Without Energy Restriction | Active comparator | Not described Receives: Behavioral: NES Without Energy Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average percent deviations from the assigned eating system score for full days, meals, and snacks for each group during each evaluation period throughout the intervention (days 23-28 and days 51-56).
Measured: 10 weeks
Secondary outcomes (4)
Change in 24 hour mean circulating glucose level from baseline to end of treatment.
Measured: 10 weeks
Change in fasting plasma glucose and insulin from baseline to end of treatment.
Measured: 10 weeks
Change in lipid parameters (Total cholesterol, LDL-C, HDL-C, triglycerides) from baseline to end of treatment.
Measured: 10 weeks
Change in dietary macronutrient composition from baseline to end of treatment.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mondelēz International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Provident Clinical Research
- Investigators
- Kevin C Maki, PhD, Study director, Provident Clinical Research & Consulting, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907075
- Sponsor's protocol ID
- PRV-08012
- Other IDs
- PRV-08012V1.9
- Status last verified
- Aug 2012
- First submitted
- 21 May 2009
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess Adherence to a Novel Eating System in Men and Women With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00907075
- Acronym / sponsor ID
- PRV-08012
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes, nutrition, diet, foods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Mondelēz International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Provident Clinical Research
- Study start
- Mar 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 22 May 2009 (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.
The purpose of this pilot study is to assess adherence to a Novel Eating System (NES) with and without energy restriction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NES With Energy Restriction | Active comparator | Behavioral: NES With Energy Restriction |
| NES Without Energy Restriction | Active comparator | Behavioral: NES Without Energy Restriction |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, 18-79 years of age, inclusive.
- Diagnosis of type 2 diabetes, at least nine months prior to screening.
- Stable use of oral hypoglycemic medication for at least two months prior to screening.
- Body mass index (BMI) ≥25.0 and <45.0 kg/m2 at screening.
- Willingness to follow a novel eating plan, which may be energy restricted to promote weight loss, throughout the trial.
Key exclusion criteria (14 listed)
- History or diagnosis of type 1 diabetes mellitus.
- Poorly controlled type 2 diabetes mellitus (HbA1C ≥9.0%).
- Weight loss or gain >10 lb (4.5 kg) in the two months prior to screening.
- Abnormal laboratory test results of clinical importance.
- History of gastrointestinal surgery for weight-reducing purposes.
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 |
|---|---|---|
| NES With Energy RestrictionThe NES will be administered based upon the individual's calculated daily energy requirement, with an energy deficit of approximately 500 kilocalories. | Behavioural | NES With Energy Restriction |
| NES Without Energy RestrictionThe NES will be administered based upon the individual's calculated daily energy requirement. | Behavioural | NES Without Energy Restriction |
Primary outcome
Average percent deviations from the assigned eating system score for full days, meals, and snacks for each group during each evaluation period throughout the intervention (days 23-28 and days 51-56).
Time frame: 10 weeks
4 secondary outcomes
Change in 24 hour mean circulating glucose level from baseline to end of treatment.
Time frame: 10 weeks
Change in fasting plasma glucose and insulin from baseline to end of treatment.
Time frame: 10 weeks
Change in lipid parameters (Total cholesterol, LDL-C, HDL-C, triglycerides) from baseline to end of treatment.
Time frame: 10 weeks
Change in dietary macronutrient composition from baseline to end of treatment.
Time frame: 10 weeks
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 22 Aug 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.
Kevin C Maki, PhD study director
Provident Clinical Research & Consulting, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NES With Energy Restriction and NES Without Energy Restriction in people with Type 2 Diabetes Mellitus, run by Mondelēz International, Inc. 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 14 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 22 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 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?
Average percent deviations from the assigned eating system score for full days, meals, and snacks for each group during each evaluation period throughout the intervention (days 23-28 and days 51-56). (time frame: 10 weeks). 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 22 Aug 2012.