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

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

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Dietary Supplement: sucralose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>intake 200 ml water daily for 3 months | Dietary Supplement: sucralose<br>* daily intake different dose of artificial sweeteners sucralose or placebo<br>|
| Experimental: low dose sucrolose group<br>intake 12.3mg sucralose in 200 ml water daily for 3 months | Dietary Supplement: sucralose<br>* daily intake different dose of artificial sweeteners sucralose or placebo<br>|
| Experimental: moderate dose sucrolose group<br>intake 73.8mg sucralose in 200ml water daily for 3 months | Dietary Supplement: sucralose<br>* daily intake different dose of artificial sweeteners sucralose or placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glucose | Fasting glucose change from baseline | 3 month | 
| postprandial blood sugar | postprandial blood glucose change from baseline | 3 month | 
| HbA1c | HbA1c change from baseline | 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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artificial sweetners, glucose metabolism, type 2 diabetic patients