Effects of Artificial Sweeteners on Glucose Metabolism in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— SWEETS  

Official title:

Effects of Artificial Sweeteners on Glucose Metabolism in Patients With Type 2 Diabetes -A Multi-Center Randomized Controlled Clinical Trial(SWEETS)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04185662
• Other study ID #: T2DM20190619
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: November 2019
• Source: RenJi Hospital
• Contact: Jing Ma, professor
• Phone: 58752345
• Email: cherry1996[@]live.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the effects of artificial sweeteners on glucose metabolism in newly diagnosed type 2 diabetic patients

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• pregancy

• Allergic to sweeteners.

• participant in any clinical trail within 3 months

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• sucralose
daily intake different dose of artificial sweeteners sucralose or placebo

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
RenJi Hospital	PuNan Hospital ,Shanghai, ShiBei Hospital , JingAn District, Shanghai, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting glucose	Fasting glucose change from baseline	3 month
Primary	postprandial blood sugar	postprandial blood glucose change from baseline	3 month
Primary	HbA1c	HbA1c change from baseline	3 month