Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes Mellitus, Low carbohydrate diet
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).
Interventions
DIETARY_SUPPLEMENTLow carbohydrate diet
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.
DIETARY_SUPPLEMENTCalori restricted diet
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%.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 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 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. |
Outcome results
None listed