Clinical trial NCT04185662: Effects of Artificial Sweeteners on Glucose Metabolism in Patients With Type 2 Diabetes
Official title: Effects of Artificial Sweeteners on Glucose Metabolism in Patients With Type 2 Diabetes -A Multi-Center Randomized Controlled Clinical Trial(SWEETS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: artificial sweetners
glucose metabolism
type 2 diabetic patients
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: ShiBei Hospital , JingAn District, Shanghai
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: PuNan Hospital ,Shanghai
First posted: 2019-12-04
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Fasting glucose
timeFrame: 3 month
measure: postprandial blood sugar
timeFrame: 3 month
measure: HbA1c
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Jing Ma, professor
role: PRINCIPAL_INVESTIGATOR
References: