Diabetes Mellitus, Type 2SDMIRNCT02813759
Sucralose in Subjects With Diabetes Mellitus Insulin Requesting
A study testing Sucralose in people with Diabetes Mellitus, Type 2, run by Universidad de Valparaiso.
Trial summary
To evaluate the acute effect of a preload of sucralose in presence of carbohydrate (HC) available on the glycemic response, postprandial C peptide and satiety in patients with type 2 diabetes mellitus (DM2) in intensive insulin therapy (IIT). Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Sucralose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jan 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum period of six month intensive insulin therapy
- Prescription rapid insulin in the breakfast
- Aged 35 to 70 years
- BMI 25 to 39.9 kg / m2
- HbA1c lower than or equal to 10% (86 mmol / mol)
- Menopausal women under hormone replacement therapy
Who cannot join
- History of intolerance artificial sweetener sucralose
- Pregnant women
- Puerperal women
- Subjects with neurological disease, endocrine disorder no treatment, kidney disease stage IV or V, cancer, liver disease, chronic obstructive pulmonary disease, HIV
- Subjects with history of stroke , acute myocardial infarction and gastrointestinal resection
About this study
Official title: Effect of a Sucralose Preload 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 preload of sucralose in presence of carbohydrate (HC) available on the glycemic response, postprandial C peptide and satiety in patients with type 2 diabetes mellitus (DM2) in intensive insulin therapy (IIT).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Sucralose, Placebo
- Keywords
- GLYCEMIA, SATIETY, C PEPTIDE, PRELOAD, INSULIN
- 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.
SucraloseOther
Subjects drank 200 mL of water with 14 mg sucralose, followed by a standard breakfast.
PlaceboOther
Also called Water
Subjects drank 200 mL of water alone (placebo), followed by a standard breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Sucralose | Experimental | 14 mg sucralose (Zero K sucralose powder, IANSA®) an 200 mL of water Receives: Other: Sucralose |
| Water | Placebo comparator | 200 mL of water Receives: Other: Placebo |
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: up to 120 minutes
C peptide
C-peptide at -15 and 60 minutes with respect to breakfast intake
Measured: up to 60 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 posted27 Jun 2016 (estimated)
- Study startJul 2015
- Primary completionNov 2015
- Study completionJan 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
- NCT02813759
- Sponsor's protocol ID
- 17/2015
- Acronym
- SDMIR
- Status last verified
- Jun 2016
- First submitted
- 16 Jun 2016
- Last updated
- 27 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lohner S, Kuellenberg de Gaudry D, Toews I, Ferenci T, Meerpohl JJ. Non-nutritive sweeteners for diabetes mellitus. Cochrane Database Syst Rev. 2020 May 25;5(5):CD012885. doi: 10.1002/14651858.CD012885.pub2.
PubMed 32449201
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Sucralose Preload on Postprandial Metabolic Parameters and Satiety in Subjects With Type 2 Diabetes Mellitus Under Intensive Insulin Therapy - Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02813759
- Acronym / sponsor ID
- SDMIR / 17/2015
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- GLYCEMIA, SATIETY, C PEPTIDE, PRELOAD, INSULIN
- 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
- Jan 2016 (actual)
- First posted
- 27 Jun 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 preload of sucralose in presence of carbohydrate (HC) available on the glycemic response, postprandial C peptide and satiety in patients with type 2 diabetes mellitus (DM2) in intensive insulin therapy (IIT).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucralose | Experimental | Other: Sucralose14 mg sucralose (Zero K sucralose powder, IANSA®) an 200 mL of water |
| Water | Placebo comparator | Other: Placebo200 mL of water |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Minimum period of six month intensive insulin therapy
- Prescription rapid insulin in the breakfast
- Aged 35 to 70 years
- BMI 25 to 39.9 kg / m2
- HbA1c lower than or equal to 10% (86 mmol / mol)
Key exclusion criteria (5 listed)
- History of intolerance artificial sweetener sucralose
- Pregnant women
- Puerperal women
- Subjects with neurological disease, endocrine disorder no treatment, kidney disease stage IV or V, cancer, liver disease, chronic obstructive pulmonary disease, HIV
- Subjects with history of stroke , acute myocardial infarction and 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 |
|---|---|---|
| SucraloseSubjects drank 200 mL of water with 14 mg sucralose, followed by a standard breakfast. | Other | Sucralose |
| PlaceboAlso: WaterSubjects drank 200 mL of water alone (placebo), followed by a standard breakfast. | Other | Water |
Primary outcome
Glycemia
Time frame: up to 120 minutes
Glycemia (mg/dL) to -15, 30, 60 and 120 minutes, with respect to breakfast intake.
C peptide
Time frame: up to 60 minutes
C-peptide at -15 and 60 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 27 Jun 2016.
- Derived from this study: PubMed 32449201Lohner S, Kuellenberg de Gaudry D, Toews I, Ferenci T, Meerpohl JJ. Non-nutritive sweeteners for diabetes mellitus. Cochrane Database Syst Rev. 2020 May 25;5(5):CD012885. doi: 10.1002/14651858.CD012885.pub2.
- 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 Sucralose 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 6 inclusion and 5 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 27 Jun 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. Some participants in this study may receive a placebo. 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: up to 120 minutes). The study lists 3 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 NCT02813759, 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 27 Jun 2016.