Diabetes Mellitus, Type 2GIDMIRNCT02881164
Glycemic Index in Subjects With Diabetes Mellitus Insulin Requesting
A study testing Low glycemic index and High glycemic index in people with Diabetes Mellitus, Type 2, run by Universidad de Valparaiso.
Trial summary
To evaluate the acute effect of a low and high glycemic index breakfast on the glycemic response and satiety in subjects with type 2 diabetes mellitus under intensive insulin therapy. Read more about this study
- Who is it for?
- Ages 47 to 64 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Low glycemic index and High glycemic index
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Aug 2016
- 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 47 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects with type 2 diabetes mellitus diagnosis.
- Minimum period of six months under intensive insulin therapy.
- Fast insulin prescription before breakfast.
- 35 and 70 years of age.
- BMI between 25 and 39.9 Kg/m2.
- HbA1c less than or equal to 10 % (86mmol/mol)
- Menopausal women under hormone replacement therapy
Who cannot join
- Pregnant women.
- Puerperal women.
- Subjects with neurological disease, endocrine disorder no treatment, kidney disease in stage IV or V, cancer, liver disease, chronic obstructive pulmonary disease, human immunodeficiency virus.
- Subjects with history of stroke, acute myocardial infarction or gastrointestinal resection.
About this study
Official title: Effect of Glycemic Index of a Preparation on Postprandial Metabolic Parameters and Satiety in Subjects With Type 2 Diabetes Mellitus Under Intensive Insulin Therapy: Controlled Clinical Trial
To evaluate the acute effect of a low and high glycemic index breakfast on the glycemic response and satiety in subjects with type 2 diabetes mellitus under intensive insulin therapy.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Low glycemic index, High glycemic index
- Keywords
- Glycemia, Satiety, Insulin, Breakfast, Low glycemic index, High glycemic index
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low glycemic indexOther
Subjects intake a low glycemic index breakfast
High glycemic indexOther
Subjects intake a high glycemic index breakfast
| Study group | Role | What they receive |
|---|---|---|
| Low glycemic index breakfast | Experimental | Low glycemic index breakfast (GI=45) Receives: Other: Low glycemic index |
| High glycemic index breakfast | Active comparator | High glycemic index breakfast (GI=80) Receives: Other: High glycemic index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemia
Glycemia (mg/dL) to -15, 30, 60 and 120 minutes, with respect to breakfast intake
Measured: -15 up to 120 minutes
Satiety
Visual Analog Scale (VAS) was applied immediate and tardy postprandial (two hours after eating breakfast).
Measured: Up to 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startJul 2015
- Primary completionNov 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Valparaiso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Vega Soto, Universidad de Valparaiso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881164
- Sponsor's protocol ID
- 17-2015
- Acronym
- GIDMIR
- Status last verified
- Aug 2016
- First submitted
- 23 Aug 2016
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lobos DR, Vicuna IA, Novik V, Vega CA. Effect of high and low glycemic index breakfast on postprandial metabolic parameters and satiety in subjects with type 2 diabetes mellitus under intensive insulin therapy: Controlled clinical trial. Clin Nutr ESPEN. 2017 Aug;20:12-16. doi: 10.1016/j.clnesp.2017.04.082. Epub 2017 May 11.
PubMed 29072163
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glycemic Index of a Preparation on Postprandial Metabolic Parameters and Satiety in Subjects With Type 2 Diabetes Mellitus Under Intensive Insulin Therapy: Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02881164
- Acronym / sponsor ID
- GIDMIR / 17-2015
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Glycemia, Satiety, Insulin, Breakfast, Low glycemic index, High glycemic index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universidad de ValparaisoUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 26 Aug 2016 (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.
To evaluate the acute effect of a low and high glycemic index breakfast on the glycemic response and satiety in subjects with type 2 diabetes mellitus under intensive insulin therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low glycemic index breakfast | Experimental | Other: Low glycemic indexLow glycemic index breakfast (GI=45) |
| High glycemic index breakfast | Active comparator | Other: High glycemic indexHigh glycemic index breakfast (GI=80) |
Who may qualify
- Ages
- 47 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects with type 2 diabetes mellitus diagnosis.
- Minimum period of six months under intensive insulin therapy.
- Fast insulin prescription before breakfast.
- 35 and 70 years of age.
- BMI between 25 and 39.9 Kg/m2.
Key exclusion criteria (4 listed)
- Pregnant women.
- Puerperal women.
- Subjects with neurological disease, endocrine disorder no treatment, kidney disease in stage IV or V, cancer, liver disease, chronic obstructive pulmonary disease, human immunodeficiency virus.
- Subjects with history of stroke, acute myocardial infarction or gastrointestinal resection.
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 glycemic indexSubjects intake a low glycemic index breakfast | Other | Low glycemic index breakfast |
| High glycemic indexSubjects intake a high glycemic index breakfast | Other | High glycemic index breakfast |
Primary outcome
Glycemia
Time frame: -15 up to 120 minutes
Glycemia (mg/dL) to -15, 30, 60 and 120 minutes, with respect to breakfast intake
Satiety
Time frame: Up to 120 minutes
Visual Analog Scale (VAS) was applied immediate and tardy postprandial (two hours after eating breakfast).
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 26 Aug 2016.
- Derived from this study: PubMed 29072163Lobos DR, Vicuna IA, Novik V, Vega CA. Effect of high and low glycemic index breakfast on postprandial metabolic parameters and satiety in subjects with type 2 diabetes mellitus under intensive insulin therapy: Controlled clinical trial. Clin Nutr ESPEN. 2017 Aug;20:12-16. doi: 10.1016/j.clnesp.2017.04.082. Epub 2017 May 11.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Low glycemic index and High glycemic index in people with Diabetes Mellitus, Type 2, run by Universidad de Valparaiso.
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 7 inclusion and 4 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 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Glycemia (time frame: -15 up to 120 minutes). The study lists 2 primary outcomes in all. 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 NCT02881164, which also lists 1 linked publication.
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 26 Aug 2016.