Diabetes Mellitus, Type 2NCT02519309

Dietary Intervention in Type-2 Diabetes and Pre-Diabetes

A study testing Virta Program in people with Diabetes Mellitus, Type 2 and Pre-diabetes, run by Virta Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The primary purpose of this research is to demonstrate the therapeutic effects of implementing a well-formulated low carbohydrate lifestyle program over 2 years in patients with type 2 diabetes, pre-diabetes, and metabolic syndrome. Read more about this study

Who is it for?: Ages 21 to 65 years
Conditions the study is for: Diabetes Mellitus, Type 2, Pre-diabetes, Metabolic Syndrome
What is being tested?: Virta Program
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 465 participants
Where: 1 siteUnited States
Study dates: Aug 2015to Apr 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 21 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Body weight/Diabetes:
Diagnosis of type-2 diabetes with BMI > 25 (without end-organ failure)
Fasting glucose >126 mg/dL or HbA1c >6.5
Body weight/ Pre-diabetes:
Diagnosis of metabolic syndrome with BMI >30 and HbA1c > 5.6 (note: this does not apply to usual care control subjects)
Ethnicity: all ethnic groups

Who cannot join

BMI <30 without diagnosis of Type-2 diabetes, metabolic syndrome
Type 1 diabetes
History of keto-acidosis
History of MI, stroke, angina, coronary insufficiency within the last 6 months
Diabetic retinopathy requiring treatment
Creatinine > 2.0

Show all 18Show fewer

Urinary albumin > 1 g/d
Impaired hepatic function (Bilirubin >2, Albumin < 3.5)
Cholelithiasis or biliary dysfunction
Cancer requiring treatment in the past 5 years, with the exception of non-melanoma skin cancer
Chronic infectious disease requiring ongoing treatment
Other chronic diseases or condition likely to limit lifespan to <6 years
Non-English speaking
Unable or unwilling to participate in group sessions (e.g., plans to relocate within the next year) or conform to a carbohydrate restricted diet lifestyle (e.g., food intolerances, religious or personal restrictions)
Weight loss of >10% in past 6 months
Currently pregnant or nursing, or planning to become pregnant during the study
Major psychiatric disorder (e.g., schizophrenia, bipolar disorder) currently uncontrolled
Excessive alcohol intake (acute or chronic) defined as average consumption of 3 or more alcohol-containing beverages daily or consumption of more than 14 alcoholic beverages per week

Trial locations and contacts

1 site in 1 country.

United States1 site

IU Health Arnett Medical Weight Loss
West Lafayette, Indiana, 47904

Other trials in United States

About this study

Official title: Dietary Intervention in Type-2 Diabetics and Pre-Diabetics Emphasizing Personalized Carbohydrate Intake

Read the detailed description

The primary purpose of this research is to demonstrate the therapeutic effects of implementing a well-formulated low carbohydrate lifestyle program over 2 years. Positive therapeutic effects would be represented by improved glycemic control in patients with type 2 diabetes without use of additional glycemic control medications and failure to progress to type 2 diabetes in individuals with pre-diabetes and metabolic syndrome.

Secondary purposes of this research are to determine if therapeutic effects of the intervention differ between patients who self-select onsite vs. web-based education delivery, explore relationships between change in LDL cholesterol and carotid intima media thickness, and to evaluate the sustainability of health outcomes achieved and the economic impact of therapeutic effects over 5 years.

Conditions: Diabetes Mellitus, Type 2, Pre-diabetes, Metabolic Syndrome
Being tested: Virta Program
Medical subject headings: Diabetes Mellitus, Type 2, Glucose Intolerance, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Virta ProgramOther

Study groups in NCT02519309
Study group	Role	What they receive
onsite	Experimental	Education (the virta program) for the onsite group will be delivered in person, with 26 classes over 12 months including group and individual sessions. Sessions will be scheduled weekly for the first 3 months, biweekly during months 4-6, and monthly thereafter. Each session will last approximately 90 minutes. Receives: Other: Virta Program
web-based	Experimental	Education (the virta program) for the web-based educational group will be the same content as the onsite group, but delivered via the web and completed at the participant's own pace. Receives: Other: Virta Program
Control (usual care)	No intervention	The study will make no intervention to this group. Participants in this group will be recent referrals to a local diabetes education program and care for their condition will continue to be managed by their own medical providers.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from Baseline Type-2 Diabetes Status
Type-2 diabetes status will be evaluated by measuring Hemoglobin A1c (HbA1c)
Measured: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Change from Baseline Metabolic Syndrome Status
Metabolic syndrome status will be evaluated by standard markers. Metabolic syndrome is defined as having at least three of the following:
- Waist circumference: ≥40 inches (men) or ≥35 inches (women)
- Fasting triglycerides: ≥150 mg/dL
- HDL-C: <40 mg/dL (men) or <50 mg/dL (women)
- Blood pressure: ≥130/85 mm Hg or use of hypertensive medication
- Fasting glucose: ≥ 100 mg/dL or use of hyperglycemia medication
Measured: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Change from Baseline Body Weight
Body weight will be evaluated on a calibrated scale
Measured: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)

Secondary outcomes (6)

Change from Baseline Carotid Intima Media Thickness (CIMT) (intervention and usual care arms, participants with type 2 diabetes only)
Ultrasound Measurement of the Carotid Artery
Measured: 12 and 24 Months
Change from Baseline Serum Lipids
Serum lipids including lipoprotein size and number
Measured: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Change from Baseline Body Composition
Body composition will be determined using dual-energy X-ray absorptiometry (DXA), which provides accurate information on total body and regional fat, lean body mass, and bone mass
Measured: 3,12 and 24 Months (intervention arms only)
Change from Baseline Type-2 Diabetes Status
Type-2 diabetes status will be evaluated by measuring Hemoglobin A1c (HbA1c)
Measured: 42 and 60 Months (intervention arms only)
Change from Baseline Metabolic Syndrome Status
Metabolic syndrome status will be evaluated by standard markers. Metabolic syndrome is defined as having at least three of the following:
- Waist circumference: ≥40 inches (men) or ≥35 inches (women)
- Fasting triglycerides: ≥150 mg/dL
- HDL-C: <40 mg/dL (men) or <50 mg/dL (women)
- Blood pressure: ≥130/85 mm Hg or use of hypertensive medication
- Fasting glucose: ≥ 100 mg/dL or use of hyperglycemia medication
Measured: 42 and 60 Months (intervention arms only)
Change from Baseline Body Weight
Body weight will be evaluated on a calibrated scale
Measured: 42 and 60 Months (intervention arms only)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2015Apr 2021

First posted10 Aug 2015 (estimated)
Study startAug 2015
Primary completionApr 2018
Study completionApr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (31)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: Non-randomised
Intervention model: Parallel groups
Model description: 1. open label, non-randomized, before-and-after study of patients with type 2 diabetes who self-select the intervention (with education delivered via onsite group classes or web-based, self-selected by participant) or usual care 2. single arm, before-and-after study of patients with prediabetes who self-select to receive the intervention (no comparison group)
Masking: None (open label)
Enrolment: 465 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02519309
Sponsor's protocol ID: 2015-1
Status last verified: Jul 2020
First submitted: 4 Aug 2015
Last updated: 27 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity among adults: United States, 2011-2012. NCHS Data Brief. 2013 Oct;(131):1-8.
PubMed 24152742
Flegal KM, Carroll MD, Ogden CL, Curtin LR. Prevalence and trends in obesity among US adults, 1999-2008. JAMA. 2010 Jan 20;303(3):235-41. doi: 10.1001/jama.2009.2014. Epub 2010 Jan 13.
PubMed 20071471
Mozumdar A, Liguori G. Persistent increase of prevalence of metabolic syndrome among U.S. adults: NHANES III to NHANES 1999-2006. Diabetes Care. 2011 Jan;34(1):216-9. doi: 10.2337/dc10-0879. Epub 2010 Oct 1.
PubMed 20889854
Petersen KF, Dufour S, Savage DB, Bilz S, Solomon G, Yonemitsu S, Cline GW, Befroy D, Zemany L, Kahn BB, Papademetris X, Rothman DL, Shulman GI. The role of skeletal muscle insulin resistance in the pathogenesis of the metabolic syndrome. Proc Natl Acad Sci U S A. 2007 Jul 31;104(31):12587-94. doi: 10.1073/pnas.0705408104. Epub 2007 Jul 18.
PubMed 17640906
Volek JS, Phinney SD, Forsythe CE, Quann EE, Wood RJ, Puglisi MJ, Kraemer WJ, Bibus DM, Fernandez ML, Feinman RD. Carbohydrate restriction has a more favorable impact on the metabolic syndrome than a low fat diet. Lipids. 2009 Apr;44(4):297-309. doi: 10.1007/s11745-008-3274-2. Epub 2008 Dec 12.
PubMed 19082851
Volek JS, Fernandez ML, Feinman RD, Phinney SD. Dietary carbohydrate restriction induces a unique metabolic state positively affecting atherogenic dyslipidemia, fatty acid partitioning, and metabolic syndrome. Prog Lipid Res. 2008 Sep;47(5):307-18. doi: 10.1016/j.plipres.2008.02.003. Epub 2008 Mar 15.
PubMed 18396172
Volek JS, Feinman RD. Carbohydrate restriction improves the features of Metabolic Syndrome. Metabolic Syndrome may be defined by the response to carbohydrate restriction. Nutr Metab (Lond). 2005 Nov 16;2:31. doi: 10.1186/1743-7075-2-31.
PubMed 16288655
Santos FL, Esteves SS, da Costa Pereira A, Yancy WS Jr, Nunes JP. Systematic review and meta-analysis of clinical trials of the effects of low carbohydrate diets on cardiovascular risk factors. Obes Rev. 2012 Nov;13(11):1048-66. doi: 10.1111/j.1467-789X.2012.01021.x. Epub 2012 Aug 21.
PubMed 22905670
Bistrian BR, Blackburn GL, Flatt JP, Sizer J, Scrimshaw NS, Sherman M. Nitrogen metabolism and insulin requirements in obese diabetic adults on a protein-sparing modified fast. Diabetes. 1976 Jun;25(6):494-504. doi: 10.2337/diab.25.6.494.
PubMed 1278601
Gumbiner B, Wendel JA, McDermott MP. Effects of diet composition and ketosis on glycemia during very-low-energy-diet therapy in obese patients with non-insulin-dependent diabetes mellitus. Am J Clin Nutr. 1996 Jan;63(1):110-5. doi: 10.1093/ajcn/63.1.110.
PubMed 8604657
Dashti HM, Al-Zaid NS, Mathew TC, Al-Mousawi M, Talib H, Asfar SK, Behbahani AI. Long term effects of ketogenic diet in obese subjects with high cholesterol level. Mol Cell Biochem. 2006 Jun;286(1-2):1-9. doi: 10.1007/s11010-005-9001-x. Epub 2006 Apr 21.
PubMed 16652223
Yancy WS Jr, Foy M, Chalecki AM, Vernon MC, Westman EC. A low-carbohydrate, ketogenic diet to treat type 2 diabetes. Nutr Metab (Lond). 2005 Dec 1;2:34. doi: 10.1186/1743-7075-2-34.
PubMed 16318637
Nielsen JV, Joensson EA. Low-carbohydrate diet in type 2 diabetes: stable improvement of bodyweight and glycemic control during 44 months follow-up. Nutr Metab (Lond). 2008 May 22;5:14. doi: 10.1186/1743-7075-5-14.
PubMed 18495047
Hussain TA, Mathew TC, Dashti AA, Asfar S, Al-Zaid N, Dashti HM. Effect of low-calorie versus low-carbohydrate ketogenic diet in type 2 diabetes. Nutrition. 2012 Oct;28(10):1016-21. doi: 10.1016/j.nut.2012.01.016. Epub 2012 Jun 5.
PubMed 22673594
Action to Control Cardiovascular Risk in Diabetes Study Group; Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Friedewald WT. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2545-59. doi: 10.1056/NEJMoa0802743. Epub 2008 Jun 6.
PubMed 18539917

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dietary Intervention in Type-2 Diabetics and Pre-Diabetics Emphasizing Personalized Carbohydrate Intake
ClinicalTrials.gov ID: NCT02519309
Acronym / sponsor ID: 2015-1
Conditions: Diabetes Mellitus, Type 2, Pre-diabetes, Metabolic Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 465 participants (actual)
Lead sponsor: Virta HealthIndustry (pharma, biotech, devices)
Study start: Aug 2015 (actual)
Primary completion: Apr 2018 (actual)
Study completion: Apr 2021 (actual)
First posted: 10 Aug 2015 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: 1. open label, non-randomized, before-and-after study of patients with type 2 diabetes who self-select the intervention (with education delivered via onsite group classes or web-based, self-selected by participant) or usual care 2. single arm, before-and-after study of patients with prediabetes who self-select to receive the intervention (no comparison group)

Arm	Type	Receives
onsite	Experimental	Other: Virta ProgramEducation (the virta program) for the onsite group will be delivered in person, with 26 classes over 12 months including group and individual sessions. Sessions will be scheduled weekly for the first 3 months, biweekly during months 4-6, and monthly thereafter. Each session will last approximately 90 minutes.
web-based	Experimental	Other: Virta ProgramEducation (the virta program) for the web-based educational group will be the same content as the onsite group, but delivered via the web and completed at the participant's own pace.
Control (usual care)	No intervention	–The study will make no intervention to this group. Participants in this group will be recent referrals to a local diabetes education program and care for their condition will continue to be managed by their own medical providers.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Diagnosis of type-2 diabetes with BMI > 25 (without end-organ failure)
Fasting glucose >126 mg/dL or HbA1c >6.5
Diagnosis of metabolic syndrome with BMI >30 and HbA1c > 5.6 (note: this does not apply to usual care control subjects)
Ethnicity: all ethnic groups

Key exclusion criteria (18 listed)

BMI <30 without diagnosis of Type-2 diabetes, metabolic syndrome
Type 1 diabetes
History of keto-acidosis
History of MI, stroke, angina, coronary insufficiency within the last 6 months
Diabetic retinopathy requiring treatment

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
Virta Program	Other	onsite, web-based

Primary outcome

Change from Baseline Type-2 Diabetes Status
Time frame: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Type-2 diabetes status will be evaluated by measuring Hemoglobin A1c (HbA1c)
Change from Baseline Metabolic Syndrome Status
Time frame: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Metabolic syndrome status will be evaluated by standard markers. Metabolic syndrome is defined as having at least three of the following: * Waist circumference: ≥40 inches (men) or ≥35 inches (women) * Fasting triglycerides: ≥150 mg/dL * HDL-C: <40 mg/dL (men) or <50 mg/dL (women) * Blood pressure: ≥130/85 mm Hg or use of hypertensive medication * Fasting glucose: ≥ 100 mg/dL or use of hyperglycemia medication
Change from Baseline Body Weight
Time frame: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Body weight will be evaluated on a calibrated scale

6 secondary outcomes

Change from Baseline Carotid Intima Media Thickness (CIMT) (intervention and usual care arms, participants with type 2 diabetes only)
Time frame: 12 and 24 Months
Change from Baseline Serum Lipids
Time frame: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Change from Baseline Body Composition
Time frame: 3,12 and 24 Months (intervention arms only)
Change from Baseline Type-2 Diabetes Status
Time frame: 42 and 60 Months (intervention arms only)
Change from Baseline Metabolic Syndrome Status
Time frame: 42 and 60 Months (intervention arms only)
Change from Baseline Body Weight
Time frame: 42 and 60 Months (intervention arms only)

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 27 Apr 2022.
Background: PubMed 24152742Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity among adults: United States, 2011-2012. NCHS Data Brief. 2013 Oct;(131):1-8.
Background: PubMed 20071471Flegal KM, Carroll MD, Ogden CL, Curtin LR. Prevalence and trends in obesity among US adults, 1999-2008. JAMA. 2010 Jan 20;303(3):235-41. doi: 10.1001/jama.2009.2014. Epub 2010 Jan 13.
Background: PubMed 20889854Mozumdar A, Liguori G. Persistent increase of prevalence of metabolic syndrome among U.S. adults: NHANES III to NHANES 1999-2006. Diabetes Care. 2011 Jan;34(1):216-9. doi: 10.2337/dc10-0879. Epub 2010 Oct 1.
Background: PubMed 17640906Petersen KF, Dufour S, Savage DB, Bilz S, Solomon G, Yonemitsu S, Cline GW, Befroy D, Zemany L, Kahn BB, Papademetris X, Rothman DL, Shulman GI. The role of skeletal muscle insulin resistance in the pathogenesis of the metabolic syndrome. Proc Natl Acad Sci U S A. 2007 Jul 31;104(31):12587-94. doi: 10.1073/pnas.0705408104. Epub 2007 Jul 18.
Background: PubMed 19082851Volek JS, Phinney SD, Forsythe CE, Quann EE, Wood RJ, Puglisi MJ, Kraemer WJ, Bibus DM, Fernandez ML, Feinman RD. Carbohydrate restriction has a more favorable impact on the metabolic syndrome than a low fat diet. Lipids. 2009 Apr;44(4):297-309. doi: 10.1007/s11745-008-3274-2. Epub 2008 Dec 12.
Background: PubMed 18396172Volek JS, Fernandez ML, Feinman RD, Phinney SD. Dietary carbohydrate restriction induces a unique metabolic state positively affecting atherogenic dyslipidemia, fatty acid partitioning, and metabolic syndrome. Prog Lipid Res. 2008 Sep;47(5):307-18. doi: 10.1016/j.plipres.2008.02.003. Epub 2008 Mar 15.
Background: PubMed 16288655Volek JS, Feinman RD. Carbohydrate restriction improves the features of Metabolic Syndrome. Metabolic Syndrome may be defined by the response to carbohydrate restriction. Nutr Metab (Lond). 2005 Nov 16;2:31. doi: 10.1186/1743-7075-2-31.
Background: PubMed 22905670Santos FL, Esteves SS, da Costa Pereira A, Yancy WS Jr, Nunes JP. Systematic review and meta-analysis of clinical trials of the effects of low carbohydrate diets on cardiovascular risk factors. Obes Rev. 2012 Nov;13(11):1048-66. doi: 10.1111/j.1467-789X.2012.01021.x. Epub 2012 Aug 21.
Background: PubMed 1278601Bistrian BR, Blackburn GL, Flatt JP, Sizer J, Scrimshaw NS, Sherman M. Nitrogen metabolism and insulin requirements in obese diabetic adults on a protein-sparing modified fast. Diabetes. 1976 Jun;25(6):494-504. doi: 10.2337/diab.25.6.494.
Background: PubMed 8604657Gumbiner B, Wendel JA, McDermott MP. Effects of diet composition and ketosis on glycemia during very-low-energy-diet therapy in obese patients with non-insulin-dependent diabetes mellitus. Am J Clin Nutr. 1996 Jan;63(1):110-5. doi: 10.1093/ajcn/63.1.110.
Background: PubMed 16652223Dashti HM, Al-Zaid NS, Mathew TC, Al-Mousawi M, Talib H, Asfar SK, Behbahani AI. Long term effects of ketogenic diet in obese subjects with high cholesterol level. Mol Cell Biochem. 2006 Jun;286(1-2):1-9. doi: 10.1007/s11010-005-9001-x. Epub 2006 Apr 21.
Background: PubMed 16318637Yancy WS Jr, Foy M, Chalecki AM, Vernon MC, Westman EC. A low-carbohydrate, ketogenic diet to treat type 2 diabetes. Nutr Metab (Lond). 2005 Dec 1;2:34. doi: 10.1186/1743-7075-2-34.

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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.

Sarah Hallberg, DO, MS principal investigator

Indiana University Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Virta Program in people with Diabetes Mellitus, Type 2 and Pre-diabetes, run by Virta Health at 1 site in United States.

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 18 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 27 Apr 2022. 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 United States. 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 Type-2 Diabetes Status (time frame: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)). The study lists 3 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 NCT02519309, which also lists 31 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 27 Apr 2022.