Type 2 Diabetes MellitusNCT04931030
Low Carbohydrate Diet in Diabetic Kidney Disease
A study testing Dietary advice in people with Type 2 Diabetes Mellitus and Diabetic Kidney Disease, run by Universiti Teknologi Mara at 1 site in Malaysia.
Trial summary
The current population of type 2 diabetes mellitus (T2DM) worldwide is over 200 million and Malaysia contributes to 1.2% of that number. The prevalence of T2DM in Malaysia has approximately tripled over the last three decades from 6.3% in 1986 to 17.5% of the adult population in 2015.T2DM is a progressive disease… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Diabetic Kidney Disease, Obesity
- What is being tested?
- Dietary advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 15 Mar 2019to 5 Mar 2021
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Type 2 DM of more than 5 years
- Diagnosis of stable CKD of more than 6 months
- CKD stage 2 and 3
- HbA1c of 7% - 10.5%
- Patient age between 40-75 years old
- Able to sign informed consent
Who cannot join
- Type 1 DM
- Frequent hypoglycaemia
- Persistent elevations of serum transminase
- Heart failure (New York Heart Association functional class III-IV), active systemic inflammatory disease, chronic renal failure requiring hemodialysis, active hepatic disease and collagen disease
- Malignancy
- Recent hospital admission for acute within the past 3 months
- Pregnant women, breastfeeding or planning to conceive within the next year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Low Carbohydrate Diet (LCBD) on Weight and Renal Outcome in Patients With Diabetic Kidney Disease (DKD)- A Pilot Study
The current population of type 2 diabetes mellitus (T2DM) worldwide is over 200 million and Malaysia contributes to 1.2% of that number. The prevalence of T2DM in Malaysia has approximately tripled over the last three decades from 6.3% in 1986 to 17.5% of the adult population in 2015.T2DM is a progressive disease associated with debilitating microvascular and macrovascular complications. The prevalence of chronic kidney disease (CKD) in Peninsular Malaysia was high at 9.1% of the adult population in 2011. T2DM is the leading cause of renal failure for patients commencing dialysis, increasing from 53% of new dialysis patients in 2004 to 61% in 2013. Therefore, diabetic kidney disease (DKD) is a debilitating complication which not only imposes significant health problems but also confers financial burden on affected patients. There has been increasing amount of understanding in the complexity of the relationship between T2DM and obesity. As the prevalence of both conditions continue to demonstrate a parallel rise, the influence of obesity on T2DM is further marked. Thus, this has led to greater emphasis on weight loss in the management of T2DM. More recent anti-diabetic medications including SGLT-2 inhibitors and GLP1 agonists demonstrated greater efficacy in improving glycaemic control and their ability to produce weight reduction. In addition, there has been more interest in the effects of these drugs on retardation of renal disease progression. The mechanism is unclear, either attributed by direct drug effects on renal glomerular-tubular structures, through the Renin-Angiotensin-Aldosterone-System (RAAS), or other pathways. Another pausible explanation is the significant weight loss, which has been shown to have a significant effect of attenuation of renal disease.
Weight reduction programs have long been a complex and tedious treatment plan which has inconsistent, non-duplicable and unpredictable outcomes. Most programs emphasized on medical nutrition therapy and lifestyle changes. There has been many different dietary plans which share a common goal ie to reduce calori intake whilst increasing energy expenditure. Few have been successfully reproducible, limited by either patient adherence or modest outcome.
Read more
Low carbohydrate diet is a diet plan which stresses on reducing carbohydrate intake to less than 20g daily. Numerous studies have shown that weight loss could be obtained by reduction of calori intake in either the form of carbohydrate or fat. CKD patients are recommended to consume low protein diet of less than 0.6-0.7g/kg/day with little emphasis on calori or carbohydrate intake.
This study, thus, aims to evaluate the effects of low carbohydrate and moderate fat (LCBD) in addition to low protein diet on renal disease in patients with DKD.
Read the detailed description
This is an investigator-initiated, single center, randomized, controlled, clinical trial in Type 2 diabetes mellitus patients, comparing 16-weeks of LCBD compared to standard medical therapy in patients with DKD.
Patients would be recruited from the Endocrinology and Nephrology clinics in UiTM Medical Specialist Center. Inclusion criteria would include patients aged between 40-75 years old, diagnosis with Type 2 DM of more than 5 years with stable CKD stage 2 and 3 of more than 6 months, HbA1c of 7% - 10.5%.
Exclusion Criteria include patients with Type 1 DM, experiencing frequent hypoglycaemia, abnormal liver function tests, heart failure (New York Heart Association functional class III-IV), active systemic inflammatory disease, chronic renal failure requiring hemodialysis, active hepatic disease and collagen disease, malignancy, recent hospital admission within the past 3 months, pregnant women, breastfeeding or planning to conceive within the next year.
Following informed consent, patients would be randomised to either LCBD or low protein Diet (LPD) group.
All recruited patients will be given the standard dietary and exercise advice which will include low protein of 0.6-0.7g/kg/day and low salt diet.
In addition, patients within the LCBD will be given a prescription diet of 20g of carbohydrate daily. This will be supplemented by visual aids on carbohydrate counts of various local food. Patients would be given the option to choose their most appropriate food types which will amount to the carbohydrate count given. Patients on oral anti-diabetic treatment including insulin will advised on titrations of their medications to avoid hypoglycaemia.
The control arm will not be given any additional advice. All patients will be required to fill in a 3-day food diary during their scheduled visits which will be at 8 weeks and 16 weeks.
Clinical assessments include blood sampling of approximately 8 ml which will be done at baseline and at study end.
- Conditions
- Type 2 Diabetes Mellitus, Diabetic Kidney Disease, Obesity
- Being tested
- Dietary advice
- Keywords
- low carbohydrate diet, chronic kidney disease, diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Nephropathies, Obesity, Renal Insufficiency, Chronic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary adviceOther
Subjects are provided dietary advice by the dietitians as part of the research team/ investigators
| Study group | Role | What they receive |
|---|---|---|
| Low carbohydrate diet (LCBD) | Experimental | Subjects are given a dietary prescription of 20g of carbohydrate daily in addition to standard low protein diet of 0.6-0.7g/kg/day and low salt diet. Receives: Other: Dietary advice |
| Low protein diet only (LPD) | No intervention | Subjects are given the standard dietary advice of chronic kidney disease of low protein diet of 0.6-0.7g/kg/day and low salt diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline serum Creatinine at 12 weeks
Creatinine in micromol/L
Measured: Study end at 12 weeks
Change from baseline urine microalbuminuria at 12 weeks
Urine microalbuminuria in mmol/L
Measured: Study end at 12 weeks
Secondary outcomes (10)
Change from baseline HbA1c at 12 weeks
HbA1c in %
Measured: Study end at 12 weeks
Change from baseline fasting plasma glucose at 12 weeks
FPG in mmol/L
Measured: Study end at 12 weeks
Change from baseline lipid levels at 12 weeks
Cholesterol in mmol/L
Measured: Study end at 12 weeks
Change from baseline weight at 12 weeks
Weight in kg
Measured: Study end at 12 weeks
Change from baseline hip circumference (HC) at 12 weeks
HC in cm
Measured: Study end at 12 weeks
Change from baseline waist circumference (WC) at 12 weeks
WC in cm
Measured: Study end at 12 weeks
Change from baseline estimated visceral adispose tissue (Est VAT) at 12 weeks
Est VAT in %
Measured: Study end at 12 weeks
Change from baseline blood pressure at 12 weeks
Blood pressure in mmHg
Measured: Study end at 12 weeks
Change from baseline highly sensitivity C-reactive protein (hsCRP) at 12 weeks
hsCRP in nmol/L
Measured: Study end at 12 weeks
Change from baseline Interleukin-6 (IL-6) at 12 weeks
IL-6 in pg/mL
Measured: Study end at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start15 Mar 2019
- Primary completion5 Mar 2021
- Study completion5 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, unblinded, dietary intervention
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Teknologi Mara
- Sponsor type
- University, hospital or other
- Collaborators
- IMU University, Malaysia
- Responsible party
- Principal investigator, Rohana Abdul Ghani, Universiti Teknologi Mara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931030
- Sponsor's protocol ID
- 600-IRMI (5/1/6)
- Status last verified
- Jun 2021
- First submitted
- 1 Jun 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Unidentified subjects' raw data is required for some journal submissions
Publications
Feisul MI, Azmi S. (Eds). National Diabetes Registry Report, Volume 1, 2009-2012. Kuala Lumpur; Ministry of Health Malaysia; 2013 Jul.
National Health and Morbidity Survey 2015 (NHMS 2015). Ministry of Health, Kuala Lumpur, Malaysia
Hooi LS, Ong LM, Ahmad G, Bavanandan S, Ahmad NA, Naidu BM, Mohamud WN, Yusoff MF. A population-based study measuring the prevalence of chronic kidney disease among adults in West Malaysia. Kidney Int. 2013 Nov;84(5):1034-40. doi: 10.1038/ki.2013.220. Epub 2013 Jun 12.
PubMed 23760287B. Goh, L. Ong, Y. Lim. Twenty First Report of the Malaysian Dialysis and Transplant 2013. Malaysian Society of Nephrology, Kuala Lumpur, Malaysia (2014)
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Carbohydrate Diet (LCBD) on Weight and Renal Outcome in Patients With Diabetic Kidney Disease (DKD)- A Pilot Study
- ClinicalTrials.gov ID
- NCT04931030
- Acronym / sponsor ID
- 600-IRMI (5/1/6)
- Conditions
- Type 2 Diabetes Mellitus, Diabetic Kidney Disease, Obesity
- Keywords
- low carbohydrate diet, chronic kidney disease, diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universiti Teknologi MaraUniversity, hospital or other
- Collaborators
- IMU University, Malaysia
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 5 Mar 2021 (actual)
- First posted
- 18 Jun 2021 (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.
The current population of type 2 diabetes mellitus (T2DM) worldwide is over 200 million and Malaysia contributes to 1.2% of that number. The prevalence of T2DM in Malaysia has approximately tripled over the last three decades from 6.3% in 1986 to 17.5% of the adult population in 2015.T2DM is a progressive disease associated with debilitating microvascular and macrovascular complications. The prevalence of chronic kidney disease (CKD) in Peninsular Malaysia was high at 9.1% of the adult population in 2011. T2DM is the leading cause of renal failure for patients commencing dialysis, increasing from 53% of new dialysis patients in 2004 to 61% in 2013. Therefore, diabetic kidney disease (DKD) is a debilitating complication which not only imposes significant health problems but also confers financial burden on affected patients. There has been increasing amount of understanding in the complexity of the relationship between T2DM and obesity. As the prevalence of both conditions continue to demonstrate a parallel rise, the influence of obesity on T2DM is further marked. Thus, this has led to greater emphasis on weight loss in the management of T2DM. More recent anti-diabetic medications including SGLT-2 inhibitors and GLP1 agonists demonstrated greater efficacy in improving glycaemic control and their ability to produce weight reduction. In addition, there has been more interest in the effects of these drugs on retardation of renal disease progression. The mechanism is unclear, either attributed by direct drug effects on renal glomerular-tubular structures, through the Renin-Angiotensin-Aldosterone-System (RAAS), or other pathways. Another pausible explanation is the significant weight loss, which has been shown to have a significant effect of attenuation of renal disease.
Weight reduction programs have long been a complex and tedious treatment plan which has inconsistent, non-duplicable and unpredictable outcomes. Most programs emphasized on medical nutrition therapy and lifestyle changes. There has been many different dietary plans which share a common goal ie to reduce calori intake whilst increasing energy expenditure. Few have been successfully reproducible, limited by either patient adherence or modest outcome.
Low carbohydrate diet is a diet plan which stresses on reducing carbohydrate intake to less than 20g daily. Numerous studies have shown that weight loss could be obtained by reduction of calori intake in either the form of carbohydrate or fat. CKD patients are recommended to consume low protein diet of less than 0.6-0.7g/kg/day with little emphasis on calori or carbohydrate intake.
This study, thus, aims to evaluate the effects of low carbohydrate and moderate fat (LCBD) in addition to low protein diet on renal disease in patients with DKD.
Detailed description
This is an investigator-initiated, single center, randomized, controlled, clinical trial in Type 2 diabetes mellitus patients, comparing 16-weeks of LCBD compared to standard medical therapy in patients with DKD.
Patients would be recruited from the Endocrinology and Nephrology clinics in UiTM Medical Specialist Center. Inclusion criteria would include patients aged between 40-75 years old, diagnosis with Type 2 DM of more than 5 years with stable CKD stage 2 and 3 of more than 6 months, HbA1c of 7% - 10.5%.
Exclusion Criteria include patients with Type 1 DM, experiencing frequent hypoglycaemia, abnormal liver function tests, heart failure (New York Heart Association functional class III-IV), active systemic inflammatory disease, chronic renal failure requiring hemodialysis, active hepatic disease and collagen disease, malignancy, recent hospital admission within the past 3 months, pregnant women, breastfeeding or planning to conceive within the next year.
Following informed consent, patients would be randomised to either LCBD or low protein Diet (LPD) group.
All recruited patients will be given the standard dietary and exercise advice which will include low protein of 0.6-0.7g/kg/day and low salt diet.
In addition, patients within the LCBD will be given a prescription diet of 20g of carbohydrate daily. This will be supplemented by visual aids on carbohydrate counts of various local food. Patients would be given the option to choose their most appropriate food types which will amount to the carbohydrate count given. Patients on oral anti-diabetic treatment including insulin will advised on titrations of their medications to avoid hypoglycaemia.
The control arm will not be given any additional advice. All patients will be required to fill in a 3-day food diary during their scheduled visits which will be at 8 weeks and 16 weeks.
Clinical assessments include blood sampling of approximately 8 ml which will be done at baseline and at study end.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled, unblinded, dietary intervention
| Arm | Type | Receives |
|---|---|---|
| Low carbohydrate diet (LCBD) | Experimental | Other: Dietary adviceSubjects are given a dietary prescription of 20g of carbohydrate daily in addition to standard low protein diet of 0.6-0.7g/kg/day and low salt diet. |
| Low protein diet only (LPD) | No intervention | –Subjects are given the standard dietary advice of chronic kidney disease of low protein diet of 0.6-0.7g/kg/day and low salt diet. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with Type 2 DM of more than 5 years
- Diagnosis of stable CKD of more than 6 months
- CKD stage 2 and 3
- HbA1c of 7% - 10.5%
- Patient age between 40-75 years old
Key exclusion criteria (7 listed)
- Type 1 DM
- Frequent hypoglycaemia
- Persistent elevations of serum transminase
- Heart failure (New York Heart Association functional class III-IV), active systemic inflammatory disease, chronic renal failure requiring hemodialysis, active hepatic disease and collagen disease
- Malignancy
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 |
|---|---|---|
| Dietary adviceSubjects are provided dietary advice by the dietitians as part of the research team/ investigators | Other | Low carbohydrate diet (LCBD) |
Primary outcome
Change from baseline serum Creatinine at 12 weeks
Time frame: Study end at 12 weeks
Creatinine in micromol/L
Change from baseline urine microalbuminuria at 12 weeks
Time frame: Study end at 12 weeks
Urine microalbuminuria in mmol/L
10 secondary outcomes
Change from baseline HbA1c at 12 weeks
Time frame: Study end at 12 weeks
Change from baseline fasting plasma glucose at 12 weeks
Time frame: Study end at 12 weeks
Change from baseline lipid levels at 12 weeks
Time frame: Study end at 12 weeks
Change from baseline weight at 12 weeks
Time frame: Study end at 12 weeks
Change from baseline hip circumference (HC) at 12 weeks
Time frame: Study end at 12 weeks
Change from baseline waist circumference (WC) at 12 weeks
Time frame: Study end at 12 weeks
Change from baseline estimated visceral adispose tissue (Est VAT) at 12 weeks
Time frame: Study end at 12 weeks
Change from baseline blood pressure at 12 weeks
Time frame: Study end at 12 weeks
Change from baseline highly sensitivity C-reactive protein (hsCRP) at 12 weeks
Time frame: Study end at 12 weeks
Change from baseline Interleukin-6 (IL-6) at 12 weeks
Time frame: Study end at 12 weeks
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 18 Jun 2021.
- BackgroundFeisul MI, Azmi S. (Eds). National Diabetes Registry Report, Volume 1, 2009-2012. Kuala Lumpur; Ministry of Health Malaysia; 2013 Jul.
- BackgroundNational Health and Morbidity Survey 2015 (NHMS 2015). Ministry of Health, Kuala Lumpur, Malaysia
- Background: PubMed 23760287Hooi LS, Ong LM, Ahmad G, Bavanandan S, Ahmad NA, Naidu BM, Mohamud WN, Yusoff MF. A population-based study measuring the prevalence of chronic kidney disease among adults in West Malaysia. Kidney Int. 2013 Nov;84(5):1034-40. doi: 10.1038/ki.2013.220. Epub 2013 Jun 12.
- BackgroundB. Goh, L. Ong, Y. Lim. Twenty First Report of the Malaysian Dialysis and Transplant 2013. Malaysian Society of Nephrology, Kuala Lumpur, Malaysia (2014)
- Individual participant dataSharing planned: Yes. Unidentified subjects' raw data is required for some journal submissions
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary advice in people with Type 2 Diabetes Mellitus and Diabetic Kidney Disease, run by Universiti Teknologi Mara at 1 site in Malaysia.
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 6 inclusion and 7 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 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change from baseline serum Creatinine at 12 weeks (time frame: Study end at 12 weeks). 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?
On the ClinicalTrials.gov record for NCT04931030, which also lists 4 linked publications.
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 18 Jun 2021.