A Rural OPTIFAST Intervention for Partial Remission of Type 2 Diabetes in Adults With Obesity

Obesity Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04764279
• Other study ID #: C-20-3
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2021
• Est. completion date: December 2022

Study information

• Verified date: February 2021
• Source: Marathon Family Health Team
• Contact: Megen T Brunskill, MD
• Phone: 807-229-3243
• Email: mbrunskill[@]mfht.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity

Intervention

Dietary Supplement:
• OPTIFAST dietary supplement
Participants will use Optifast Nutrition Supplement as previously described

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Marathon Family Health Team

References & Publications (12)

Ard 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. — View Citation

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. — View Citation

Bilandzic 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. English, French. — View Citation

Hallberg SJ, Gershuni VM, Hazbun TL, Athinarayanan SJ. Reversing Type 2 Diabetes: A Narrative Review of the Evidence. Nutrients. 2019 Apr 1;11(4). pii: E766. doi: 10.3390/nu11040766. Review. — View Citation

Lean 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. — View Citation

Leslie 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. Review. Erratum in: Int J Obes (Lond). 2017 Jun;41(6):997. — View Citation

Lewis 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. — View Citation

Miura 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. — View Citation

O'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. — View Citation

Pohar 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. — View Citation

Supina 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. — View Citation

Yawn BP, Casey M, Hebert P. The rural health care workforce implications of practice guideline implementation. Med Care. 1999 Mar;37(3):259-69. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Partial Remission of Diabetes	HbA1c<6.5% without antihyperglycemic medications	12 months
Secondary	Improved Insulin Resistance	Reduction of Fasting Insulin	12 months
Secondary	Improved Blood Pressure	Reduction in blood pressure measures	12 months
Secondary	Weight loss	Reduction in BMI	12 months
Secondary	Reduction in Visceral Adiposity	Reduction in waist circumference	12 months

External Links

•   Canadian Diabetes Strategy
•   Diabetes in Canada
•   NorthWest LHIN Diabetes Health Team Strategy
•   Reversibility of Type 2 Diabetes