Type 2 Diabetes MellitusNCT03176056
The Effectiveness of Low Carbohydrate Diet in Reducing Polypharmacy for Patients With Type 2 Diabetes Mellitus
A study testing Low carbohydrate diet and Calori restricted diet in people with Type 2 Diabetes Mellitus, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Low carbohydrate diet and Calori restricted diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2016to 28 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- eating disorders
- could not complete the questionnaire
- poor compliance to protocol.
About this study
Official title: 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.
Read the 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).
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Low carbohydrate diet, Calori restricted diet
- Keywords
- Type 2 Diabetes Mellitus, Low carbohydrate diet
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low carbohydrate dietDietary 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 dietDietary 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%.
| Study group | Role | What they receive |
|---|---|---|
| Low carbohydrate diet | Experimental | Low carbohydrate diet limits carbohydrate <=90g/day Receives: Dietary Supplement: Low carbohydrate diet |
| Calori restricted diet | Active comparator | Traditional diabetic diet Receives: Dietary Supplement: Calori restricted diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: measured at baseline and every 3 months for 18 months after intervention
Secondary outcomes (5)
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: measured at baseline and every 3 months for 18 months after intervention
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: 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: 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: 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: measured at baseline and 18 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start2 Feb 2016
- Primary completion28 Jan 2018
- Study completion28 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chin-Ying Chen, MD, MHSc, Study chair, National Taiwan University Hospital and National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176056
- Sponsor's protocol ID
- 201504032RINA
- Status last verified
- Sep 2018
- First submitted
- 31 May 2017
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Carbohydrate Diet for Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03176056
- Acronym / sponsor ID
- 201504032RINA
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Low carbohydrate diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 2 Feb 2016 (actual)
- Primary completion
- 28 Jan 2018 (actual)
- Study completion
- 28 Jan 2018 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Low carbohydrate diet | Experimental | Dietary Supplement: Low carbohydrate dietLow carbohydrate diet limits carbohydrate <=90g/day |
| Calori restricted diet | Active comparator | Dietary Supplement: Calori restricted dietTraditional diabetic diet |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low carbohydrate dietFor 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 supplement | Low carbohydrate diet |
| Calori restricted dietFor 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%. | Dietary supplement | Calori restricted diet |
Primary outcome
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.
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.
5 secondary outcomes
The improvement of lipid profile
Time frame: 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 maintenance of renal function
Time frame: 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 improvement of carotid intima-media thickness (IMT)
Time frame: measured at baseline and 18 month after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chin-Ying Chen, MD, MHSc study chair
National Taiwan University Hospital and National Taiwan University
Questions about this trial
What is this clinical trial studying?
A study testing Low carbohydrate diet and Calori restricted diet in people with Type 2 Diabetes Mellitus, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement of glycemic control status (time frame: measured at baseline and every 3 months for 18 months after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.