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

NCT03176056 | Completed

• 1 other identifier: 201504032RINA
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus; Low carbohydrate diet

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• 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

Study Arms (2)

Low carbohydrate diet

EXPERIMENTAL

Low carbohydrate diet limits carbohydrate \<=90g/day

Dietary Supplement: Low carbohydrate diet

Calori restricted diet

ACTIVE COMPARATOR

Traditional diabetic diet

Dietary Supplement: Calori restricted diet

Interventions

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.

Low carbohydrate diet

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%.

Calori restricted diet

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Chin-Ying Chen, MD, MHSc

  National Taiwan University Hospital and National Taiwan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 5, 2017
• Study Start: February 2, 2016
• Primary Completion: January 28, 2018
• Study Completion: January 28, 2018
• Last Updated: October 2, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share