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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Dietary Supplement: Low carbohydrate diet; Dietary Supplement: Calori restricted diet

• Registration Number: NCT03176056
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed 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).

Study Timeline

• Study Start: 2016-02-02
• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-01
• Study First Posted: 2017-06-05
• Primary Completion: 2018-01-28
• Study Completion: 2018-01-28
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-30
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low carbohydrate diet	Low carbohydrate diet	Low carbohydrate diet limits carbohydrate \<=90g/day
Calori restricted diet	Calori restricted diet	Traditional diabetic diet

Primary Outcome Measures

Name	Time	Method
The reduction of medication effect score (MES)	measured at baseline and every 3 months for 18 months after intervention	The MES assessed the overall utilization of hypoglycemic agents. The percentage of the maximum daily dose for each medication was multiplied by an adjustment factor and these products were summed to produce the final MES value. A higher MES value denoted a greater use of medication. The minimum score is 0 and without maximum score.The lower, the better. The reduction of MES over the 18 months after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.
The improvement of glycemic control status	measured at baseline and every 3 months for 18 months after intervention	The reduction of HbA1c, fasting and 2-h glucose over the 18 months after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.

Secondary Outcome Measures

Name	Time	Method
The improvement of small dense low density lipoprotein (sdLDL)	measured at baseline and every 6 months for 18 months after intervention	The reduction of sdLDL after intervention.The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.
The improvement of carotid intima-media thickness (IMT)	measured at baseline and 18 month after intervention	The reduction of carotid IMT after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.
The improvement of lipid profile	measured at baseline and every 3 months for 18 months after intervention	The reduction of total cholesterol, triglyceride, LDL and the increment of HDL after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.
The improvement of microalbuminuria.	measured at baseline and 18 month after intervention	The reduction of microalbumin/creatine ratio after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.
The maintenance of renal function	measured at baseline and every 3 months for 18 months after intervention	The change of serum creatinine after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.