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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Diabetes Mellitus, Type 2

Treatments: Dietary Supplement: sucralose

Study type: Interventional

Funder types: Other

Identifiers

NCT04185662

T2DM20190619

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

intake 200 ml water daily for 3 months

Treatment:

Dietary Supplement: sucralose

low dose sucrolose group

Experimental group

Description:

intake 12.3mg sucralose in 200 ml water daily for 3 months

Treatment:

Dietary Supplement: sucralose

moderate dose sucrolose group

Experimental group

Description:

intake 73.8mg sucralose in 200ml water daily for 3 months

Treatment:

Dietary Supplement: sucralose