Trial | NCT04185662  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    120
To investigate the effects of artificial sweeteners on glucose metabolism in newly diagnosed type 2 diabetic patients
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 Started
Dec 01
2019
Anticipated
Primary Completion
Aug 30
2021
Anticipated
Study Completion
Sep 30
2021
Anticipated
Last Update
Dec 04
2019

Dietary Supplement sucralose

daily intake different dose of artificial sweeteners sucralose or placebo

placebo Placebo Comparator

intake 200 ml water daily for 3 months

low dose sucrolose group Experimental

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

moderate dose sucrolose group Experimental

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

Criteria 

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
No Results Posted