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

NCT ID: NCT04185662

Last Updated: 2019-12-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2021-09-30

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

placebo

intake 200 ml water daily for 3 months

Group Type: PLACEBO_COMPARATOR

sucralose

Intervention Type: DIETARY_SUPPLEMENT

daily intake different dose of artificial sweeteners sucralose or placebo

low dose sucrolose group

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

Group Type: EXPERIMENTAL

sucralose

Intervention Type: DIETARY_SUPPLEMENT

daily intake different dose of artificial sweeteners sucralose or placebo

moderate dose sucrolose group

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

Group Type: EXPERIMENTAL

sucralose

Intervention Type: DIETARY_SUPPLEMENT

daily intake different dose of artificial sweeteners sucralose or placebo

Interventions

sucralose

daily intake different dose of artificial sweeteners sucralose or placebo

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ShiBei Hospital , JingAn District, Shanghai

UNKNOWN

Sponsor Role: collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

PuNan Hospital ,Shanghai

UNKNOWN

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jing Ma, professor

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

Renji Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Jing Ma, professor

Role: CONTACT

cherry1996@live.cn

58752345 ext. 3083

Other Identifiers

T2DM20190619

Identifier Type: -

Identifier Source: org_study_id