Diabetes Mellitus, Type 2SWEETSNCT04185662
Effects of Artificial Sweeteners on Glucose Metabolism in Patients With Type 2 Diabetes
A study testing sucralose in people with Diabetes Mellitus, Type 2, run by RenJi Hospital at 1 site in China.
Trial summary
To investigate the effects of artificial sweeteners on glucose metabolism in newly diagnosed type 2 diabetic patients Read more about this study
- Who is it for?
- Ages 30 to 60 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
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 30 Sep 2021
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants with newly diagnosed type 2 diabetes, diagnosed by World Health Organization criteria, were recruited from outpatient of the Endocrinology Department in Shanghai Renji Hospital, Shanghai PuNan hospital，Shanghai ShiBei hospital, shanghai xinhua hospital, chongming branch;
- FBG≤ 9 mmol/L, HbA1c≤ 7% ;without any oral hypoglycemic agents or insulin,
- Age ≥30 and ≤ 60 years old.
- BMI >24 and <28 kg/m2; --no regular consumption of artificial sweeteners or foods that have added much sweeteners.(eg:Coca-Cola zero), no sucralose intolerance.
Who cannot join
- patients who had a history of acute and chronic diarrhea or constipation or severe chronic gastrointestinal disease..
- underwent enterectomy or other abdominal surgery (e.g., gallbladder removal) within one year;
- take antibiotics, antidiarrheic, antispasmodic, steroids and immune agents within three months.
- Patients who had a history of abnormal renal function(creatinine >132μmol/L), active liver disease(ALT were 2.5 times higher than the normal upper limit), or accompany with other sever diseases, such as severe infection, severe anemia, neutropenia and mental illness.
- Other serious heart disease, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated heart disease,cardiac function(NYHA) classification>level III.
- A history of acute complications such as diabetic ketoacidosis or hypertonic coma within 3 months.
Show all 9Show fewer
- pregancy
- Allergic to sweeteners.
- participant in any clinical trail within 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Artificial Sweeteners on Glucose Metabolism in Patients With Type 2 Diabetes -A Multi-Center Randomized Controlled Clinical Trial(SWEETS)
To investigate the effects of artificial sweeteners on glucose metabolism in newly diagnosed type 2 diabetic patients
Read the detailed description
Artificial sweeteners are among the most widely used food additives worldwide. Artificial sweeteners consumption is considered safe and beneficial owing to their low caloric content. However, recent studies demonstrated that consumption of commonly used artificial sweeteners formulations drives the development of glucose intolerance in healthy human subjects. However,the effects of artificial sweeter on glucose metabolism in newly diagnosed type 2 diabetic patients remains unknown. Thus, different doses of sweeteners will be given to newly diagnosed type 2 diabetic patients to investigate the effects of artificial sweeteners on glucose metabolism.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- sucralose
- Keywords
- artificial sweetners, glucose metabolism, type 2 diabetic patients
- 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.
sucraloseDietary supplement
daily intake different dose of artificial sweeteners sucralose or placebo
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | intake 200 ml water daily for 3 months Receives: Dietary Supplement: sucralose |
| low dose sucrolose group | Experimental | intake 12.3mg sucralose in 200 ml water daily for 3 months Receives: Dietary Supplement: sucralose |
| moderate dose sucrolose group | Experimental | intake 73.8mg sucralose in 200ml water daily for 3 months Receives: Dietary Supplement: sucralose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting glucose
Fasting glucose change from baseline
Measured: 3 month
postprandial blood sugar
postprandial blood glucose change from baseline
Measured: 3 month
HbA1c
HbA1c change from baseline
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start1 Dec 2019 (estimated)
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by RenJi 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ShiBei Hospital , JingAn District, Shanghai, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, PuNan Hospital ,Shanghai
- Responsible party
- Sponsor
- Investigators
- Jing Ma, professor, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185662
- Sponsor's protocol ID
- T2DM20190619
- Acronym
- SWEETS
- Status last verified
- Nov 2019
- First submitted
- 30 Nov 2019
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Artificial Sweeteners on Glucose Metabolism in Patients With Type 2 Diabetes -A Multi-Center Randomized Controlled Clinical Trial(SWEETS)
- ClinicalTrials.gov ID
- NCT04185662
- Acronym / sponsor ID
- SWEETS / T2DM20190619
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- artificial sweetners, glucose metabolism, type 2 diabetic patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- ShiBei Hospital , JingAn District, Shanghai, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, PuNan Hospital ,Shanghai
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 4 Dec 2019 (actual)
- 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 investigate the effects of artificial sweeteners on glucose metabolism in newly diagnosed type 2 diabetic patients
Detailed description
Artificial sweeteners are among the most widely used food additives worldwide. Artificial sweeteners consumption is considered safe and beneficial owing to their low caloric content. However, recent studies demonstrated that consumption of commonly used artificial sweeteners formulations drives the development of glucose intolerance in healthy human subjects. However,the effects of artificial sweeter on glucose metabolism in newly diagnosed type 2 diabetic patients remains unknown. Thus, different doses of sweeteners will be given to newly diagnosed type 2 diabetic patients to investigate the effects of artificial sweeteners on glucose metabolism.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: sucraloseintake 200 ml water daily for 3 months |
| low dose sucrolose group | Experimental | Dietary Supplement: sucraloseintake 12.3mg sucralose in 200 ml water daily for 3 months |
| moderate dose sucrolose group | Experimental | Dietary Supplement: sucraloseintake 73.8mg sucralose in 200ml water daily for 3 months |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants with newly diagnosed type 2 diabetes, diagnosed by World Health Organization criteria, were recruited from outpatient of the Endocrinology Department in Shanghai Renji Hospital, Shanghai PuNan hospital，Shanghai ShiBei hospital, shanghai xinhua hospital, chongming branch;
- FBG≤ 9 mmol/L, HbA1c≤ 7% ;without any oral hypoglycemic agents or insulin,
- Age ≥30 and ≤ 60 years old.
- BMI >24 and <28 kg/m2; --no regular consumption of artificial sweeteners or foods that have added much sweeteners.(eg:Coca-Cola zero), no sucralose intolerance.
Key exclusion criteria (9 listed)
- patients who had a history of acute and chronic diarrhea or constipation or severe chronic gastrointestinal disease..
- underwent enterectomy or other abdominal surgery (e.g., gallbladder removal) within one year;
- take antibiotics, antidiarrheic, antispasmodic, steroids and immune agents within three months.
- Patients who had a history of abnormal renal function(creatinine >132μmol/L), active liver disease(ALT were 2.5 times higher than the normal upper limit), or accompany with other sever diseases, such as severe infection, severe anemia, neutropenia and mental illness.
- Other serious heart disease, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated heart disease,cardiac function(NYHA) classification>level III.
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 |
|---|---|---|
| sucralosedaily intake different dose of artificial sweeteners sucralose or placebo | Dietary supplement | low dose sucrolose group, moderate dose sucrolose group, placebo |
Primary outcome
Fasting glucose
Time frame: 3 month
Fasting glucose change from baseline
postprandial blood sugar
Time frame: 3 month
postprandial blood glucose change from baseline
HbA1c
Time frame: 3 month
HbA1c change from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- 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.
Jing Ma, professor principal investigator
RenJi 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 sucralose in people with Diabetes Mellitus, Type 2, run by RenJi Hospital at 1 site in China.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 4 Dec 2019. 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 China. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Ma, professor (58752345 ext. 3083, cherry1996@live.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting glucose (time frame: 3 month). 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?
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 4 Dec 2019.