Patients With Type 2 DiabetesNCT03727854
Effect of Premeal Protein-bar on Glycemic Control in Patients With Type 2 Diabetes
A study testing Premeal protein enriched bar and Dietary modification in people with Patients With Type 2 Diabetes, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to evaluate the effect of premeal protein-enriched bar in long-term glycemic control in patients with type 2 diabetes mellitus. Glucose levels in subjects who intake premeal protein-enriched bar with dietary modification will be compared to those in subjects who only do the dietary… Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Patients With Type 2 Diabetes
- What is being tested?
- Premeal protein enriched bar and Dietary modification
- 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 siteSouth Korea
- Study dates
- 27 Aug 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI 18.5~35 kg/m2
- Type 2 diabetes patients
- Fasting blood glucose ≥ 126 mg/dl or
- HbA1c ≥ 6.5% or
- Subjects who were previously diagnosed with type 2 diabetes and who have been treated with lifestyle modification only, oral anti-diabetic drugs or basal insulin.
Who cannot join
- HbA1c < 6.5% or > 10%
- Subjects using insulin other than basal insulin
- Subjects who have newly started or have changed anti diabetic drugs within 3 months
- Subjects who are allergic to grains, nuts, legumes and milk
- Previous history of gastrointestinal surgery (except for hemorrhoid surgery, appendectomy surgery and hernia surgery)
- Subjects with chronic unstable disease
Show all 11Show fewer
- Subjects with cognitive impairments who are not able to follow the study protocol
- Females who are pregnant or doing breast feeding
- Subjects with Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels of higher than 3 times of upper normal ranges
- Subjects with hemoglobin level of less than 10.0 g/dL
- Subjects with alcohol addiction or drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Premeal Consumption of Protein-enriched, Dietary Fiber-fortified Cereal Bar on Long-term Glycemic Control in Patients With Type 2 Diabetes
The aim of this study is to evaluate the effect of premeal protein-enriched bar in long-term glycemic control in patients with type 2 diabetes mellitus. Glucose levels in subjects who intake premeal protein-enriched bar with dietary modification will be compared to those in subjects who only do the dietary modification.
Read the detailed description
Forty subjects with type 2 diabetes will be recruited. Every subject will be randomized in two groups, which are premeal protein bar with dietary modification group and dietary modification only group. The study will be conducted for 12 weeks for each participants. All participants will receive diabetes diet education. Intervention group will consume protein-enriched bar before each meals (at least twice a day) and control group will follow diabetes diet education without other additional supplements. Primary outcome is change of HbA1c from baseline for 12 weeks, and secondary outcomes are changes of fasting blood glucose level, body weight, waist circumference, blood lipid level, HOMA-IR and HOMA-beta from baseline for 12 weeks.
- Conditions
- Patients With Type 2 Diabetes
- Being tested
- Premeal protein enriched bar, Dietary modification
- Keywords
- protein-enriched bar, glycemic control, type 2 diabetes, long term
- 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.
Premeal protein enriched barDietary supplement
Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day).
Dietary modificationBehavioural
Subjects in this group will follow diabetes diet education.
| Study group | Role | What they receive |
|---|---|---|
| Premeal protein group | Experimental | Premeal protein enriched bar with dietary modification Receives: Dietary Supplement: Premeal protein enriched bar; Behavioral: Dietary modification |
| Dietary modofication only group | Other | Dietary modification only Receives: Behavioral: Dietary modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c From Baseline
Measured: 0 week, 12 weeks
Secondary outcomes (8)
Change in Fasting Blood Glucose Level From Baseline
Measured: 0 week, 12 weeks
Change in Body Weight From Baseline
Measured: 0 week, 12 weeks
Change in Waist Circumference From Baseline
Measured: 0 week, 12 weeks
Change in Blood Triglyceride Level From Baseline
Measured: 0 week, 12 weeks
Change in Blood High-density Lipoprotein Level From Baseline
Measured: 0 week, 12 weeks
Change in Blood Low-density Lipoprotein Level From Baseline
Measured: 0 week, 12 weeks
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) From Baseline
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is an index to estimate the insulin resistance of a subject. HOMA-IR is defined as ( glucose (mg/dl) X insulin (uIU/ml) ) / 405.
Measured: 0 week, 12 weeks
Change in Homeostatic Model Assessment of β-cell Function (HOMA-beta) From Baseline
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is an index to estimate the insulin resistance of a subject. HOMA-IR is defined as ( glucose (mg/dl) X insulin (uIU/ml) ) / 405.
Measured: 0 week, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start27 Aug 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Patients With Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Min Cho, Seoul National University Hospital
- Investigators
- Young Min Cho, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727854
- Sponsor's protocol ID
- H-1804-120-940
- Status last verified
- Apr 2020
- First submitted
- 31 Oct 2018
- Last updated
- 13 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Premeal Consumption of Protein-enriched, Dietary Fiber-fortified Cereal Bar on Long-term Glycemic Control in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03727854
- Acronym / sponsor ID
- H-1804-120-940
- Conditions
- Patients With Type 2 Diabetes
- Keywords
- protein-enriched bar, glycemic control, type 2 diabetes, long term
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 1 Nov 2018 (actual)
- Results
- Posted 13 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the effect of premeal protein-enriched bar in long-term glycemic control in patients with type 2 diabetes mellitus. Glucose levels in subjects who intake premeal protein-enriched bar with dietary modification will be compared to those in subjects who only do the dietary modification.
Detailed description
Forty subjects with type 2 diabetes will be recruited. Every subject will be randomized in two groups, which are premeal protein bar with dietary modification group and dietary modification only group. The study will be conducted for 12 weeks for each participants. All participants will receive diabetes diet education. Intervention group will consume protein-enriched bar before each meals (at least twice a day) and control group will follow diabetes diet education without other additional supplements. Primary outcome is change of HbA1c from baseline for 12 weeks, and secondary outcomes are changes of fasting blood glucose level, body weight, waist circumference, blood lipid level, HOMA-IR and HOMA-beta from baseline for 12 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premeal protein group | Experimental | Dietary Supplement: Premeal protein enriched bar, Behavioral: Dietary modificationPremeal protein enriched bar with dietary modification |
| Dietary modofication only group | Other | Behavioral: Dietary modificationDietary modification only |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI 18.5~35 kg/m2
- Type 2 diabetes patients
- Fasting blood glucose ≥ 126 mg/dl or
- HbA1c ≥ 6.5% or
- Subjects who were previously diagnosed with type 2 diabetes and who have been treated with lifestyle modification only, oral anti-diabetic drugs or basal insulin.
Key exclusion criteria (11 listed)
- HbA1c < 6.5% or > 10%
- Subjects using insulin other than basal insulin
- Subjects who have newly started or have changed anti diabetic drugs within 3 months
- Subjects who are allergic to grains, nuts, legumes and milk
- Previous history of gastrointestinal surgery (except for hemorrhoid surgery, appendectomy surgery and hernia surgery)
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 |
|---|---|---|
| Premeal protein enriched barSubjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day). | Dietary supplement | Premeal protein group |
| Dietary modificationSubjects in this group will follow diabetes diet education. | Behavioural | Dietary modofication only group, Premeal protein group |
Primary outcome
Change in HbA1c From Baseline
Time frame: 0 week, 12 weeks
8 secondary outcomes
Change in Fasting Blood Glucose Level From Baseline
Time frame: 0 week, 12 weeks
Change in Body Weight From Baseline
Time frame: 0 week, 12 weeks
Change in Waist Circumference From Baseline
Time frame: 0 week, 12 weeks
Change in Blood Triglyceride Level From Baseline
Time frame: 0 week, 12 weeks
Change in Blood High-density Lipoprotein Level From Baseline
Time frame: 0 week, 12 weeks
Change in Blood Low-density Lipoprotein Level From Baseline
Time frame: 0 week, 12 weeks
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) From Baseline
Time frame: 0 week, 12 weeks
Change in Homeostatic Model Assessment of β-cell Function (HOMA-beta) From Baseline
Time frame: 0 week, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Young Min Cho, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Premeal protein enriched bar and Dietary modification in people with Patients With Type 2 Diabetes, run by Seoul National University Hospital at 1 site in South Korea.
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 11 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 13 Apr 2020. 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 South Korea. 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?
Yes. Results are posted in the registry (first posted 13 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 HbA1c From Baseline (time frame: 0 week, 12 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 13 Apr 2020.