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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low carbohydrate diet | Experimental | Low carbohydrate diet limits carbohydrate <=90g/day |
|
| Calori restricted diet | Active Comparator | Traditional diabetic diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low carbohydrate diet | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The improvement of glycemic control status | 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. | measured at baseline and every 3 months for 18 months after intervention |
| The reduction of medication effect score (MES) | 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. | measured at baseline and every 3 months for 18 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| The improvement of lipid profile | 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. | measured at baseline and every 3 months for 18 months after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chin-Ying Chen, MD, MHSc | National Taiwan University Hospital and National Taiwan University | Study Chair |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 31, 2016 | Sep 29, 2018 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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Randomized controlled trial
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| Calori restricted diet | Dietary Supplement | 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%. |
|
| The improvement of small dense low density lipoprotein (sdLDL) | 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. | measured at baseline and every 6 months for 18 months after intervention |
| The maintenance of renal function | 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. | measured at baseline and every 3 months for 18 months after intervention |
| The improvement of microalbuminuria. | 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. | measured at baseline and 18 month after intervention |
| The improvement of carotid intima-media thickness (IMT) | 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. | measured at baseline and 18 month after intervention |
| D004700 | Endocrine System Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |