The Effectiveness of Low Carbohydrate Diet in Reducing Polypharmacy for Patients With Type 2 Diabetes Mellitus

National Taiwan University

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Dietary Supplement: Calori restricted diet; Dietary Supplement: Low carbohydrate diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03176056

201504032RINA

Details and patient eligibility

About

This study determines whether an educational intervention with a 90 g/day LCD is safe, effective and has good compliance for poorly controlled type 2 diabetes patients.

Full description

Poorly controlled type 2 diabetic men and women, aged between 20 and 80 years, with HbA1c≧ 7.5% (58mmol/mol) in the previous 3 months participated in this randomized controlled 18-month trial at a medical center. Patients were randomly assigned to the interventional group and given a 90g/day low carbohydrate diet (LCD) or the controlled group, which maintained a standard calorie-restricted diet (CRD). All patients received periodic educational intervention and were monitored for weight, body composition, waist girth, hip girth, thigh girth, pre- and post-prandial serum glucose, HbA1c, lipid profile(Cholesterol, Triglyceride. HDL, LDL, sdLDL), renal function, microalbumin/cre, carotid intima-media thickness (IMT),and medication effect score (MES).

Enrollment: 92 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes diagnosis ≧ 1 year
• poorly controlled with HbA1c≧ 7.5% in the previous 3 months.
• aged 20 to 80
• without or with treatment [ oral hypoglycemic agents (OHA) and/or insulin treatment)

Exclusion criteria

• pregnancy or lactating women
• impaired renal function with serum creatinine ≧ 1.5 mg/dl
• abnormal liver function [alanine aminotransferase (ALT), aspartate aminotransferase (AST), ≧ 3 times the normal upper limit) or liver cirrhosis
• significant heart diseases (unstable angina, unstable heart failure)
• frequent gout attacks (≧ 3 times/year)
• participation in other weight loss programs or the use of weight-reducing drugs
• eating disorders
• could not complete the questionnaire
• poor compliance to protocol.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Low carbohydrate diet

Experimental group

Description:

Low carbohydrate diet limits carbohydrate \<=90g/day

Treatment:

Dietary Supplement: Low carbohydrate diet

Calori restricted diet

Active Comparator group

Description:

Traditional diabetic diet

Treatment:

Dietary Supplement: Calori restricted diet