- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03176056
The Effectiveness of Low Carbohydrate Diet in Reducing Polypharmacy for Patients With Type 2 Diabetes Mellitus
September 30, 2018 updated by: National Taiwan University Hospital
Low Carbohydrate Diet for 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
92
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low carbohydrate diet
Low carbohydrate diet limits carbohydrate <=90g/day
|
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.
|
Active Comparator: Calori restricted diet
Traditional diabetic 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%.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
measured at baseline and every 3 months for 18 months after intervention
|
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.
|
measured at baseline and every 3 months for 18 months after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
measured at baseline and every 3 months for 18 months after intervention
|
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.
|
measured at baseline and every 6 months for 18 months after intervention
|
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.
|
measured at baseline and every 3 months for 18 months after intervention
|
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.
|
measured at baseline and 18 month after intervention
|
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.
|
measured at baseline and 18 month after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Chin-Ying Chen, MD, MHSc, National Taiwan University Hospital and National Taiwan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 2, 2016
Primary Completion (Actual)
January 28, 2018
Study Completion (Actual)
January 28, 2018
Study Registration Dates
First Submitted
May 31, 2017
First Submitted That Met QC Criteria
June 1, 2017
First Posted (Actual)
June 5, 2017
Study Record Updates
Last Update Posted (Actual)
October 2, 2018
Last Update Submitted That Met QC Criteria
September 30, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201504032RINA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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