Diabetes Mellitus, Type 2NCT04764279
A Rural OPTIFAST Intervention for Partial Remission of Type 2 Diabetes in Adults With Obesity
A study testing OPTIFAST dietary supplement in people with Diabetes Mellitus, Type 2 and Obesity, run by Marathon Family Health Team.
Trial summary
As rural Canada is a resource poor health service environment, we propose to test whether an OPTIFAST dietary replacement intervention, without the service intensive behavioural component, can cause partial remission of DMII in patients with obesity and DMII. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- OPTIFAST dietary supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Dec 2022
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study participants will be patients of the MFHT, aged 18 to 65, BMI between 27 and 45 kg/m 2 , and newly diagnosed with DMII within the past 6 years.
Who cannot join
- The exclusion criteria will be anti-hyperglycemic medications, slow onset of type 1 diabetes (DMI) or maturity onset diabetes of the young (MODY), renal dysfunction (serum creatinine>150 μmol/l), history of myocardial infarction, untreated thyroid disease, consumption of 4 alcohol units/day by men and 3 units/day by women, chronic steroid consumption, unstable psychiatric conditions, and atypical antipsychotic medication.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Rural-specific OPTIFAST Intervention - A Randomized Study for Partial Remission of Type 2 Diabetes in Patients With Obesity Between the Age of 18 and 65
As rural Canada is a resource poor health service environment, we propose to test whether an OPTIFAST dietary replacement intervention, without the service intensive behavioural component, can cause partial remission of DMII in patients with obesity and DMII.
Read the detailed description
The objective of this study is to see if a rural-specific OPTIFAST intervention, of dietary replacement only, can cause a partial remission of DMII patients with obesity between the age of 18 and 65 diagnosed with DMII within the last 6 years. The goal is to inform the current diabetes routine care by standardizing a rural protocol on the effectiveness of rural-specific OPTIFAST intervention for people with DMII who want to attain partial remission of DMII.
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Being tested
- OPTIFAST dietary supplement
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTIFAST dietary supplementDietary supplement
Participants will use Optifast Nutrition Supplement as previously described
| Study group | Role | What they receive |
|---|---|---|
| OPTIFAST Arm | Experimental | Participants in the intervention group will be given OPTIFAST® meal replacement shakes, 4 per day to achieve 900kcal/day, for the first 12 weeks of the study. The second phase will consist of partial meal replacement and food reintroduction over a 4 week period. When the intervention group begins to reintroduce foods, all study participants will be provided a workbook, created for the study, to explain optimal lifestyle changes for DMII management. The third phase will be a 8-month follow-up of participants on continued healthy lifestyle as described in the workbook. Receives: Dietary Supplement: OPTIFAST dietary supplement |
| Control/Usual Care Arm | No intervention | Usual Care : A gift card will be offered to participants in the control group to stabilize the incentive of the intervention. Participants in the control group will receive usual diabetes care based on the current Canadian Diabetes Association guidelines by their family physician. Participants in the control group will receive the same workbook as the intervention group at 16 weeks into the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial Remission of Diabetes
HbA1c<6.5% without antihyperglycemic medications
Measured: 12 months
Secondary outcomes (4)
Improved Insulin Resistance
Reduction of Fasting Insulin
Measured: 12 months
Improved Blood Pressure
Reduction in blood pressure measures
Measured: 12 months
Weight loss
Reduction in BMI
Measured: 12 months
Reduction in Visceral Adiposity
Reduction in waist circumference
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study startJun 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- A two arm, open-label randomized study will be conducted with a total of 30 patients being randomly assigned (1:1) to either of the two study arms: VLCD ( OPTIFAST®) intervention or best-practice care (control). The sample size was determined assuming a 46% partial remission rate of DMII in the VLCD group at year 1 and 4% in the usual care group and power of 80%. These rates are based on the findings of the DiRECT study.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marathon Family Health Team
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Megen Brunskill, Marathon Family Health Team
- Investigators
- Megen T Brunskill, MD, Principal investigator, Marathon Family Health Team
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764279
- Sponsor's protocol ID
- C-20-3
- Status last verified
- Feb 2021
- First submitted
- 17 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Athinarayanan SJ, Adams RN, Hallberg SJ, McKenzie AL, Bhanpuri NH, Campbell WW, Volek JS, Phinney SD, McCarter JP. Long-Term Effects of a Novel Continuous Remote Care Intervention Including Nutritional Ketosis for the Management of Type 2 Diabetes: A 2-Year Non-randomized Clinical Trial. Front Endocrinol (Lausanne). 2019 Jun 5;10:348. doi: 10.3389/fendo.2019.00348. eCollection 2019.
PubMed 31231311Ard JD, Lewis KH, Rothberg A, Auriemma A, Coburn SL, Cohen SS, Loper J, Matarese L, Pories WJ, Periman S. Effectiveness of a Total Meal Replacement Program (OPTIFAST Program) on Weight Loss: Results from the OPTIWIN Study. Obesity (Silver Spring). 2019 Jan;27(1):22-29. doi: 10.1002/oby.22303. Epub 2018 Nov 13.
PubMed 30421863Bilandzic A, Rosella L. The cost of diabetes in Canada over 10 years: applying attributable health care costs to a diabetes incidence prediction model. Health Promot Chronic Dis Prev Can. 2017 Feb;37(2):49-53. doi: 10.24095/hpcdp.37.2.03.
PubMed 28273040Leslie WS, Taylor R, Harris L, Lean ME. Weight losses with low-energy formula diets in obese patients with and without type 2 diabetes: systematic review and meta-analysis. Int J Obes (Lond). 2017 Jan;41(1):96-101. doi: 10.1038/ijo.2016.175. Epub 2015 Oct 4.
PubMed 27698345Pohar SL, Majumdar SR, Johnson JA. Health care costs and mortality for Canadian urban and rural patients with diabetes: population-based trends from 1993-2001. Clin Ther. 2007;29 Spec No:1316-24.
PubMed 18046931Supina AL, Guirguis LM, Majumdar SR, Lewanczuk RZ, Lee TK, Toth EL, Johnson JA. Treatment gaps for hypertension management in rural Canadian patients with type 2 diabetes mellitus. Clin Ther. 2004 Apr;26(4):598-606. doi: 10.1016/s0149-2918(04)90062-8.
PubMed 15189757Hallberg SJ, Gershuni VM, Hazbun TL, Athinarayanan SJ. Reversing Type 2 Diabetes: A Narrative Review of the Evidence. Nutrients. 2019 Apr 1;11(4):766. doi: 10.3390/nu11040766.
PubMed 30939855Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.
PubMed 29221645Lewis MC, Phillips ML, Slavotinek JP, Kow L, Thompson CH, Toouli J. Change in liver size and fat content after treatment with Optifast very low calorie diet. Obes Surg. 2006 Jun;16(6):697-701. doi: 10.1381/096089206777346682.
PubMed 16756727Miura J, Arai K, Tsukahara S, Ohno M, Ikeda Y. The long term effectiveness of combined therapy by behavior modification and very low calorie diet: 2 years follow-up. Int J Obes. 1989;13 Suppl 2:73-7.
PubMed 2613431Yawn BP, Casey M, Hebert P. The rural health care workforce implications of practice guideline implementation. Med Care. 1999 Mar;37(3):259-69. doi: 10.1097/00005650-199903000-00006.
PubMed 10098570O'Neil PM, Miller-Kovach K, Tuerk PW, Becker LE, Wadden TA, Fujioka K, Hollander PL, Kushner RF, Timothy Garvey W, Rubino DM, Malcolm RJ, Weiss D, Raum WJ, Salyer JL, Hermayer KL, Rost SL, Veliko JL, Sora ND. Randomized controlled trial of a nationally available weight control program tailored for adults with type 2 diabetes. Obesity (Silver Spring). 2016 Nov;24(11):2269-2277. doi: 10.1002/oby.21616.
PubMed 27804264
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rural-specific OPTIFAST Intervention - A Randomized Study for Partial Remission of Type 2 Diabetes in Patients With Obesity Between the Age of 18 and 65
- ClinicalTrials.gov ID
- NCT04764279
- Acronym / sponsor ID
- C-20-3
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Marathon Family Health TeamUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 21 Feb 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.
As rural Canada is a resource poor health service environment, we propose to test whether an OPTIFAST dietary replacement intervention, without the service intensive behavioural component, can cause partial remission of DMII in patients with obesity and DMII.
Detailed description
The objective of this study is to see if a rural-specific OPTIFAST intervention, of dietary replacement only, can cause a partial remission of DMII patients with obesity between the age of 18 and 65 diagnosed with DMII within the last 6 years. The goal is to inform the current diabetes routine care by standardizing a rural protocol on the effectiveness of rural-specific OPTIFAST intervention for people with DMII who want to attain partial remission of DMII.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A two arm, open-label randomized study will be conducted with a total of 30 patients being randomly assigned (1:1) to either of the two study arms: VLCD ( OPTIFAST®) intervention or best-practice care (control). The sample size was determined assuming a 46% partial remission rate of DMII in the VLCD group at year 1 and 4% in the usual care group and power of 80%. These rates are based on the findings of the DiRECT study.
| Arm | Type | Receives |
|---|---|---|
| OPTIFAST Arm | Experimental | Dietary Supplement: OPTIFAST dietary supplementParticipants in the intervention group will be given OPTIFAST® meal replacement shakes, 4 per day to achieve 900kcal/day, for the first 12 weeks of the study. The second phase will consist of partial meal replacement and food reintroduction over a 4 week period. When the intervention group begins to reintroduce foods, all study participants will be provided a workbook, created for the study, to explain optimal lifestyle changes for DMII management. The third phase will be a 8-month follow-up of participants on continued healthy lifestyle as described in the workbook. |
| Control/Usual Care Arm | No intervention | –Usual Care : A gift card will be offered to participants in the control group to stabilize the incentive of the intervention. Participants in the control group will receive usual diabetes care based on the current Canadian Diabetes Association guidelines by their family physician. Participants in the control group will receive the same workbook as the intervention group at 16 weeks into the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Study participants will be patients of the MFHT, aged 18 to 65, BMI between 27 and 45 kg/m 2 , and newly diagnosed with DMII within the past 6 years.
Key exclusion criteria (1 listed)
- The exclusion criteria will be anti-hyperglycemic medications, slow onset of type 1 diabetes (DMI) or maturity onset diabetes of the young (MODY), renal dysfunction (serum creatinine>150 μmol/l), history of myocardial infarction, untreated thyroid disease, consumption of 4 alcohol units/day by men and 3 units/day by women, chronic steroid consumption, unstable psychiatric conditions, and atypical antipsychotic medication.
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 |
|---|---|---|
| OPTIFAST dietary supplementParticipants will use Optifast Nutrition Supplement as previously described | Dietary supplement | OPTIFAST Arm |
Primary outcome
Partial Remission of Diabetes
Time frame: 12 months
HbA1c<6.5% without antihyperglycemic medications
4 secondary outcomes
Improved Insulin Resistance
Time frame: 12 months
Improved Blood Pressure
Time frame: 12 months
Weight loss
Time frame: 12 months
Reduction in Visceral Adiposity
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Background: PubMed 31231311Athinarayanan SJ, Adams RN, Hallberg SJ, McKenzie AL, Bhanpuri NH, Campbell WW, Volek JS, Phinney SD, McCarter JP. Long-Term Effects of a Novel Continuous Remote Care Intervention Including Nutritional Ketosis for the Management of Type 2 Diabetes: A 2-Year Non-randomized Clinical Trial. Front Endocrinol (Lausanne). 2019 Jun 5;10:348. doi: 10.3389/fendo.2019.00348. eCollection 2019.
- Background: PubMed 30421863Ard JD, Lewis KH, Rothberg A, Auriemma A, Coburn SL, Cohen SS, Loper J, Matarese L, Pories WJ, Periman S. Effectiveness of a Total Meal Replacement Program (OPTIFAST Program) on Weight Loss: Results from the OPTIWIN Study. Obesity (Silver Spring). 2019 Jan;27(1):22-29. doi: 10.1002/oby.22303. Epub 2018 Nov 13.
- Background: PubMed 28273040Bilandzic A, Rosella L. The cost of diabetes in Canada over 10 years: applying attributable health care costs to a diabetes incidence prediction model. Health Promot Chronic Dis Prev Can. 2017 Feb;37(2):49-53. doi: 10.24095/hpcdp.37.2.03.
- Background: PubMed 27698345Leslie WS, Taylor R, Harris L, Lean ME. Weight losses with low-energy formula diets in obese patients with and without type 2 diabetes: systematic review and meta-analysis. Int J Obes (Lond). 2017 Jan;41(1):96-101. doi: 10.1038/ijo.2016.175. Epub 2015 Oct 4.
- Background: PubMed 18046931Pohar SL, Majumdar SR, Johnson JA. Health care costs and mortality for Canadian urban and rural patients with diabetes: population-based trends from 1993-2001. Clin Ther. 2007;29 Spec No:1316-24.
- Background: PubMed 15189757Supina AL, Guirguis LM, Majumdar SR, Lewanczuk RZ, Lee TK, Toth EL, Johnson JA. Treatment gaps for hypertension management in rural Canadian patients with type 2 diabetes mellitus. Clin Ther. 2004 Apr;26(4):598-606. doi: 10.1016/s0149-2918(04)90062-8.
- Background: PubMed 30939855Hallberg SJ, Gershuni VM, Hazbun TL, Athinarayanan SJ. Reversing Type 2 Diabetes: A Narrative Review of the Evidence. Nutrients. 2019 Apr 1;11(4):766. doi: 10.3390/nu11040766.
- Background: PubMed 29221645Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.
- Background: PubMed 16756727Lewis MC, Phillips ML, Slavotinek JP, Kow L, Thompson CH, Toouli J. Change in liver size and fat content after treatment with Optifast very low calorie diet. Obes Surg. 2006 Jun;16(6):697-701. doi: 10.1381/096089206777346682.
- Background: PubMed 2613431Miura J, Arai K, Tsukahara S, Ohno M, Ikeda Y. The long term effectiveness of combined therapy by behavior modification and very low calorie diet: 2 years follow-up. Int J Obes. 1989;13 Suppl 2:73-7.
- Background: PubMed 10098570Yawn BP, Casey M, Hebert P. The rural health care workforce implications of practice guideline implementation. Med Care. 1999 Mar;37(3):259-69. doi: 10.1097/00005650-199903000-00006.
- Background: PubMed 27804264O'Neil PM, Miller-Kovach K, Tuerk PW, Becker LE, Wadden TA, Fujioka K, Hollander PL, Kushner RF, Timothy Garvey W, Rubino DM, Malcolm RJ, Weiss D, Raum WJ, Salyer JL, Hermayer KL, Rost SL, Veliko JL, Sora ND. Randomized controlled trial of a nationally available weight control program tailored for adults with type 2 diabetes. Obesity (Silver Spring). 2016 Nov;24(11):2269-2277. doi: 10.1002/oby.21616.
- Canadian Diabetes StrategyLink provided by the sponsor.
- Reversibility of Type 2 DiabetesLink provided by the sponsor.
- 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.
Megen T Brunskill, MD principal investigator
Marathon Family Health Team
Questions about this trial
What is this clinical trial studying?
A study testing OPTIFAST dietary supplement in people with Diabetes Mellitus, Type 2 and Obesity, run by Marathon Family Health Team.
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 1 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: status not confirmed, as of the sponsor's last update on 21 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Megen T Brunskill, MD (807-229-3243, mbrunskill@mfht.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partial Remission of Diabetes (time frame: 12 months). 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 NCT04764279, which also lists 12 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 21 Feb 2021.