Effects of Artificial Sweeteners on Glucose Metabolism in Patients With Type 2 Diabetes -A Multi-Center Randomized Controlled Clinical Trial(SWEETS)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- RenJi Hospital
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Fasting glucose
Study Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Allergic to sweeteners.
- •participant in any clinical trail within 3 months
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported