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NCT Number: NCT03176056

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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%.

Primary outcomes

  1. The improvement of glycemic control status

    Time frame: 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.

  2. The reduction of medication effect score (MES)

    Time frame: 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 outcomes

  1. The improvement of lipid profile

    Time frame: 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.

  2. The improvement of small dense low density lipoprotein (sdLDL)

    Time frame: 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.

  3. The maintenance of renal function

    Time frame: 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.

  4. The improvement of microalbuminuria.

    Time frame: 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.

  5. The improvement of carotid intima-media thickness (IMT)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Low Carbohydrate Diet for Type 2 Diabetes Mellitus

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 5, 2017
Registry last updated
Oct 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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