Diet ModificationNCT03181165
Pharmacist-led Therapeutic Nutritional Intervention in Type 2 Diabetes
A study testing Low-carbohydrate Therapeutic Nutrition in people with Diet Modification, run by University of British Columbia at 1 site in Canada.
Trial summary
Type 2 diabetes represents a significant burden to both the individual and our healthcare system. Individuals with type 2 diabetes are typically prescribed one or more glucose-lowering medications, many of which have undesirable side effects (e.g., nausea, risk of cardiovascular complications, weight gain) and cost… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diet Modification
- What is being tested?
- Low-carbohydrate Therapeutic Nutrition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jul 2017to 15 Jul 2020
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 30 and 75, have type 2 diabetes mellitus diagnosed by a physician, are taking one or more glucose-lowering medications, have a BMI ≥30, have no contraindications to following low-carbohydrate, energy-restricted, high-protein diet, and can read and speak English.
Who cannot join
- Exlcusion criteria are:
- Recent (within the last 2 years) diagnosis of coronary heart disease, stroke, or a heart attack.
- Unstable cardiovascular disorder.
- History of liver disease.
- History of kidney disease or impaired renal function.
- Previously undergone bariatric surgery.
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- Multiple sclerosis or other diagnosed neurological disease.
- Currently pregnant or lactating, or planning on becoming pregnant in the next 12 months.
- Any form of cancer within the last 5 years.
- Body mass index (BMI) of <30.
- Dietary restrictions that do not allow you to follow a low-carbohydrate, energy-restricted, high-protein diet (e.g., vegan, food allergies).
- Any sensitivities to the ingredients in the pre-packaged foods
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Pharmacist-led Therapeutic Nutritional Intervention on Medications and Glucose Control in Type 2 Diabetes
Type 2 diabetes represents a significant burden to both the individual and our healthcare system. Individuals with type 2 diabetes are typically prescribed one or more glucose-lowering medications, many of which have undesirable side effects (e.g., nausea, risk of cardiovascular complications, weight gain) and cost our healthcare system a lot of money. An alternative strategy to lower blood glucose is to consume a low-carbohydrate diet. However, adjusting medications after choosing to follow a low-carbohydrate diet can be difficult. Delivering a low-carbohydrate diet through pharmacists could circumvent this difficulty in medications adjustment because pharmacists are trained to adjust medications. In this study the investigators will determine whether type 2 diabetes patients can reduce medications and improve blood glucose by following a low-carbohydrate, low-calorie diet under the direction of a pharmacist.
- Conditions
- Diet Modification
- Being tested
- Low-carbohydrate Therapeutic Nutrition
- Keywords
- Low-carbohydrate, Low calorie, Energy restricted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-carbohydrate Therapeutic NutritionBehavioural
The pharmacist or pharmacy lifestyle coach will work with the participant to develop a diet plan that is low in carbohydrate and energy-restricted based on personal preferences and characteristics. A combination of pre-packaged low-carbohydrate foods and whole foods from pre-specified lists will be used.
| Study group | Role | What they receive |
|---|---|---|
| Low-carbohydrate Therapeutic Nutrition | Experimental | A 12-week low-carbohydrate, energy-restricted diet will be administered using a combination of pre-packaged foods and whole foods from pre-specified lists. Receives: Behavioral: Low-carbohydrate Therapeutic Nutrition |
| Treatment-as-usual waitlist control | No intervention | Participants will receive standard lifestyle advice to follow a low-fat, low-sugar, high fibre diet and aim to accumulate 150 minutes of moderate activity per week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants not on glucose-lowering medications
Number of individuals taking no medications divided by the total number of participants.
Measured: 12 weeks
Secondary outcomes (16)
Hemoglobin A1C
Blood test to measure glucose control
Measured: 12 weeks
Reduction in glucose-lowering medications
Reduction in total dose of glucose-lowering medications
Measured: 12 weeks
Body mass index
Body mass in kilograms divided by height in meters squared.
Measured: 12 weeks
Waist circumference
Waist circumference in centimeters
Measured: 12 weeks
Body fat percentage
Body fat percentage measured by bioelectrical impedance analysis
Measured: 12 weeks
Body mass
Body mass in kg
Measured: 12 weeks
Health related quality of life
Short-form (SF)-20 questionnaire
Measured: 12 weeks
Reduction in non-glucose lowering medications
Dose of medications other than glucose-lowering
Measured: 12 weeks
Blood lipid profile
triglycerides, HDL and LDL cholesterol
Measured: 12 weeks
Fasting insulin
Fasting insulin
Measured: 12 weeks
Fasting C-peptide
fasting C-peptide
Measured: 12 weeks
C-reactive protein
Fasting high-sensitivity C-reactive protein
Measured: 12 weeks
Liver enzymes
liver alanine amino transferase, aspartate aminotransferase, gamma-gluatmyl transpeptidase
Measured: 12 weeks
Fasting plasma glucose
Fasting plasma glucose
Measured: 12 weeks
Systolic Blood Pressure
Systolic Blood Pressure measured by automatic cuff
Measured: 12 weeks
Diastolic Blood Pressure
Diastolic Blood Pressure measured by automatic cuff
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start5 Jul 2017
- Primary completion15 Nov 2019
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diet ModificationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic effectiveness trial of diet intervention led by community pharmacists versus treatment-as-usual waitlist control.
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Mitacs, Pharmasave
- Responsible party
- Principal investigator, Jonathan Little, University of British Columbia
- Investigators
- Jonathan P Little, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181165
- Sponsor's protocol ID
- H16-01539
- Status last verified
- Sep 2020
- First submitted
- 6 Jun 2017
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual values will be reported in figures if applicable.
Publications
Durrer C, Islam H, Cen HH, Garzon MDM, Lyu X, McKelvey S, Singer J, Batterham AM, Long JZ, Johnson JD, Little JP. A secondary analysis of indices of hepatic and beta cell function following 12 weeks of carbohydrate and energy restriction vs. free-living control in adults with type 2 diabetes. Nutr Metab (Lond). 2024 May 27;21(1):29. doi: 10.1186/s12986-024-00807-x.
PubMed 38797835Durrer C, McKelvey S, Singer J, Batterham AM, Johnson JD, Gudmundson K, Wortman J, Little JP. A randomized controlled trial of pharmacist-led therapeutic carbohydrate and energy restriction in type 2 diabetes. Nat Commun. 2021 Sep 10;12(1):5367. doi: 10.1038/s41467-021-25667-4.
PubMed 34508090Durrer C, McKelvey S, Singer J, Batterham AM, Johnson JD, Wortman J, Little JP. Pharmacist-led therapeutic carbohydrate restriction as a treatment strategy for type 2 diabetes: the Pharm-TCR randomized controlled trial protocol. Trials. 2019 Dec 27;20(1):781. doi: 10.1186/s13063-019-3873-7.
PubMed 31881991
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Pharmacist-led Therapeutic Nutritional Intervention on Medications and Glucose Control in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03181165
- Acronym / sponsor ID
- H16-01539
- Conditions
- Diet Modification
- Keywords
- Low-carbohydrate, Low calorie, Energy restricted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Mitacs, Pharmasave
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 8 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.
Type 2 diabetes represents a significant burden to both the individual and our healthcare system. Individuals with type 2 diabetes are typically prescribed one or more glucose-lowering medications, many of which have undesirable side effects (e.g., nausea, risk of cardiovascular complications, weight gain) and cost our healthcare system a lot of money. An alternative strategy to lower blood glucose is to consume a low-carbohydrate diet. However, adjusting medications after choosing to follow a low-carbohydrate diet can be difficult. Delivering a low-carbohydrate diet through pharmacists could circumvent this difficulty in medications adjustment because pharmacists are trained to adjust medications. In this study the investigators will determine whether type 2 diabetes patients can reduce medications and improve blood glucose by following a low-carbohydrate, low-calorie diet under the direction of a pharmacist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic effectiveness trial of diet intervention led by community pharmacists versus treatment-as-usual waitlist control.
| Arm | Type | Receives |
|---|---|---|
| Low-carbohydrate Therapeutic Nutrition | Experimental | Behavioral: Low-carbohydrate Therapeutic NutritionA 12-week low-carbohydrate, energy-restricted diet will be administered using a combination of pre-packaged foods and whole foods from pre-specified lists. |
| Treatment-as-usual waitlist control | No intervention | –Participants will receive standard lifestyle advice to follow a low-fat, low-sugar, high fibre diet and aim to accumulate 150 minutes of moderate activity per week. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Between the ages of 30 and 75, have type 2 diabetes mellitus diagnosed by a physician, are taking one or more glucose-lowering medications, have a BMI ≥30, have no contraindications to following low-carbohydrate, energy-restricted, high-protein diet, and can read and speak English.
Key exclusion criteria (12 listed)
- Recent (within the last 2 years) diagnosis of coronary heart disease, stroke, or a heart attack.
- Unstable cardiovascular disorder.
- History of liver disease.
- History of kidney disease or impaired renal function.
- Previously undergone bariatric surgery.
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 Therapeutic NutritionThe pharmacist or pharmacy lifestyle coach will work with the participant to develop a diet plan that is low in carbohydrate and energy-restricted based on personal preferences and characteristics. A combination of pre-packaged low-carbohydrate foods and whole foods from pre-specified lists will be used. | Behavioural | Low-carbohydrate Therapeutic Nutrition |
Primary outcome
Proportion of participants not on glucose-lowering medications
Time frame: 12 weeks
Number of individuals taking no medications divided by the total number of participants.
16 secondary outcomes
Hemoglobin A1C
Time frame: 12 weeks
Reduction in glucose-lowering medications
Time frame: 12 weeks
Body mass index
Time frame: 12 weeks
Waist circumference
Time frame: 12 weeks
Body fat percentage
Time frame: 12 weeks
Body mass
Time frame: 12 weeks
Health related quality of life
Time frame: 12 weeks
Reduction in non-glucose lowering medications
Time frame: 12 weeks
Blood lipid profile
Time frame: 12 weeks
Fasting insulin
Time frame: 12 weeks
Fasting C-peptide
Time frame: 12 weeks
C-reactive protein
Time frame: 12 weeks
Liver enzymes
Time frame: 12 weeks
Fasting plasma glucose
Time frame: 12 weeks
Systolic Blood Pressure
Time frame: 12 weeks
Diastolic Blood Pressure
Time frame: 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 11 Sep 2020.
- Derived from this study: PubMed 38797835Durrer C, Islam H, Cen HH, Garzon MDM, Lyu X, McKelvey S, Singer J, Batterham AM, Long JZ, Johnson JD, Little JP. A secondary analysis of indices of hepatic and beta cell function following 12 weeks of carbohydrate and energy restriction vs. free-living control in adults with type 2 diabetes. Nutr Metab (Lond). 2024 May 27;21(1):29. doi: 10.1186/s12986-024-00807-x.
- Derived from this study: PubMed 34508090Durrer C, McKelvey S, Singer J, Batterham AM, Johnson JD, Gudmundson K, Wortman J, Little JP. A randomized controlled trial of pharmacist-led therapeutic carbohydrate and energy restriction in type 2 diabetes. Nat Commun. 2021 Sep 10;12(1):5367. doi: 10.1038/s41467-021-25667-4.
- Derived from this study: PubMed 31881991Durrer C, McKelvey S, Singer J, Batterham AM, Johnson JD, Wortman J, Little JP. Pharmacist-led therapeutic carbohydrate restriction as a treatment strategy for type 2 diabetes: the Pharm-TCR randomized controlled trial protocol. Trials. 2019 Dec 27;20(1):781. doi: 10.1186/s13063-019-3873-7.
- Individual participant dataSharing planned: No. Individual values will be reported in figures if applicable.
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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.
Jonathan P Little, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-carbohydrate Therapeutic Nutrition in people with Diet Modification, run by University of British Columbia at 1 site in Canada.
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 1 inclusion and 12 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 11 Sep 2020. 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 Canada. 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?
Proportion of participants not on glucose-lowering medications (time frame: 12 weeks). 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 NCT03181165, which also lists 3 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 11 Sep 2020.