Low Carbohydrate Diet for Type 2 Diabetes Mellitus

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

Sponsors

Lead sponsor: National Taiwan University Hospital

Source 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).

Overall Status Completed
Start Date February 2, 2016
Completion Date January 28, 2018
Primary Completion Date January 28, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
The improvement of glycemic control status measured at baseline and every 3 months for 18 months after intervention
The reduction of medication effect score (MES) measured at baseline and every 3 months for 18 months after intervention
Secondary Outcome
Measure Time Frame
The improvement of lipid profile measured at baseline and every 3 months for 18 months after intervention
The improvement of small dense low density lipoprotein (sdLDL) measured at baseline and every 6 months for 18 months after intervention
The maintenance of renal function measured at baseline and every 3 months for 18 months after intervention
The improvement of microalbuminuria. measured at baseline and 18 month after intervention
The improvement of carotid intima-media thickness (IMT) measured at baseline and 18 month after intervention
Enrollment 92
Condition
Intervention

Intervention type: Dietary Supplement

Intervention name: Low carbohydrate diet

Description: For the LCD group, the daily carbohydrate intake was limited to less than 90g, without any restriction to total energy. The concept of a LCD was introduced and an educational 15 g equivalent carbohydrate food list was provided. The easy conversion method is that 15 g equivalent carbohydrate =1/4 bowel of rice= 1/2 bowel of noodle = 1 slice of toast = 3 soup-spoon of oats = one bowl of fruit =1/2 regular size banana= one glass of milk = 3 dumplings. Less than two equivalent 15g-carbohydrate intakes per meal were advised.

Arm group label: Low carbohydrate diet

Intervention type: Dietary Supplement

Intervention name: Calori restricted diet

Description: For the calori restricted diet group, the target total calorie intake was calculated by multiplying the ideal body weight by 25 kcal/kg for those with a BMI in the range 18.5 to 24, 20 kcal/kg for obese subjects with a BMI > 24 and 30 kcal/day for underweight subjects with a BMI <18.5. The macronutrient percentage was 50-60% for carbohydrate, 1.0-1.2 g/kg for protein and fat ≦30%.

Arm group label: Calori restricted diet

Eligibility

Criteria:

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.

Gender: All

Minimum age: 20 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Chin-Ying Chen, MD, MHSc Study Chair National Taiwan University Hospital and National Taiwan University
Verification Date

September 2018

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Low carbohydrate diet

Arm group type: Experimental

Description: Low carbohydrate diet limits carbohydrate <=90g/day

Arm group label: Calori restricted diet

Arm group type: Active Comparator

Description: Traditional diabetic diet

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Randomized controlled trial

Primary purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov