Vivo for Prediabetes

Overseen By Recruiter

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Impactiv, Inc.

Must not be taking: Antidiabetics, Testosterone

Disqualifiers: Unstable angina, Arrhythmia, Uncontrolled hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 25

Duration: 12 weeks

90 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are taking antidiabetic medications or testosterone supplements, you will need to stop them to participate in this trial. The protocol does not specify about other medications.

What data supports the effectiveness of the treatment Vivo for prediabetes?

Research shows that lifestyle interventions, including diet and exercise, are effective in preventing type 2 diabetes in people with prediabetes. Additionally, medications like metformin have shown benefits in managing prediabetes, suggesting that targeted interventions can help delay or prevent the progression to type 2 diabetes. ^{1 2 3 4 5}

How does the treatment Vivo for prediabetes differ from other treatments?

The treatment Vivo for prediabetes is unique because it may offer a novel approach compared to the widely studied lifestyle interventions and metformin, which are the most common treatments. While the specifics of Vivo are not detailed, it could potentially target different mechanisms or offer a new method of administration, setting it apart from existing options. ^{4 6 7 8 9}

What is the purpose of this trial?

This is a 12-week randomized, controlled trial that seeks to examine the effect of Vivo on 1) change in lower extremity strength defined as number of chair stands done in 30 seconds and 2) change in average glycemic level (HbA1c) compared to a wait list control.

Eligibility Criteria

This trial is for older adults who are not very active and have prediabetes, a condition where blood sugar levels are higher than normal but not high enough to be type 2 diabetes. They should be experiencing muscle weakness or loss due to aging.

Inclusion Criteria

I can walk and live at home.

Sedentary: less than 150 minutes of moderate physical activity OR less than 60 minutes of vigorous physical activity per week

Have not engaged in resistance training for at least 6 months prior to enrollment

Exclusion Criteria

I cannot complete physical function tests.

I have had an amputation or paralysis in my lower body.

Weight instability (defined as gain or loss of ≥10% over the last 6 months)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments for physical function and glycemic levels

1 week

1 visit (in-person)

Treatment

Participants in the Vivo intervention meet virtually twice a week for 12 weeks with a certified trainer

12 weeks

24 visits (virtual)

Follow-up

Participants are monitored for changes in physical function and glycemic levels after treatment

4 weeks

Treatment Details

Interventions

• Vivo

Trial Overview The study tests Vivo's effects on physical function, specifically leg strength measured by the number of chair stands in half a minute, and its impact on blood sugar control as indicated by HbA1c levels over a period of 12 weeks compared to those who wait for treatment.

Participant Groups

Group I: Vivo intervention Experimental Treatment 1 Intervention

Participants will meet virtually twice a week for 12 weeks with their small group and certified trainer for 45 minutes.

Group II: Waitlist control Active Control 1 Intervention

Participants randomized to this arm will be asked to maintain their baseline physical activity for 12-weeks. They will be scheduled for the baseline and 12-week assessment and following the 12-week assessment, they will be offered enrollment into Vivo.

Who Is Running the Clinical Trial?

Impactiv, Inc.

Lead Sponsor

Trials

2

Recruited

420+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Findings from Research

Prediabetes is a significant health concern that increases the risk of developing type 2 diabetes (T2DM) and associated complications, but it can be effectively managed through lifestyle changes and medications.

Various treatments, including lifestyle interventions, medications like metformin and GLP-1 receptor agonists, and even bariatric surgery, have been shown to prevent or delay the progression from prediabetes to T2DM, highlighting the importance of individualized management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating prediabetes: why and how should we do it? Braga, T., Kraemer-Aguiar, LG., Docherty, NG., et al.[2019]

The current definition of prediabetes is rigid and does not account for the diverse underlying mechanisms and risk factors, particularly inflammation, that contribute to its progression towards diabetes and cardiovascular disease.

Identifying and phenotyping the prediabetic population into more specific groups could enhance long-term risk assessment and prevention strategies, allowing for better monitoring of those at higher risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phenotyping the Prediabetic Population-A Closer Look at Intermediate Glucose Status and Cardiovascular Disease. Barbu, E., Popescu, MR., Popescu, AC., et al.[2023]

In a study of 105 patients with prediabetes, targeted pharmacologic interventions using insulin sensitizers (pioglitazone + metformin) significantly improved glucose tolerance, with 14.3% reverting to normal glucose levels after treatment.

The combination of insulin sensitizers and exenatide showed even greater efficacy, with 59.1% of patients reverting to normal glucose tolerance, highlighting the effectiveness of tailored therapies in reversing prediabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful treatment of prediabetes in clinical practice: targeting insulin resistance and β-cell dysfunction. Armato, J., DeFronzo, RA., Abdul-Ghani, M., et al.[2022]

Prediabetes significantly increases the risk of developing type 2 diabetes and is associated with complications similar to those seen in diabetes, highlighting the importance of early intervention.

Intensive lifestyle changes and metformin have been shown to effectively prevent or delay the onset of type 2 diabetes in individuals with prediabetes, with lifestyle interventions generally being more effective, and long-term follow-ups indicate that early interventions can lead to lasting health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascular complications in prediabetes and type 2 diabetes: a continuous process arising from a common pathology. Gottwald-Hostalek, U., Gwilt, M.[2022]

In a study of 1,105 individuals with prediabetes, those identified as high risk (HR) benefited significantly from an intensified lifestyle intervention (LI), showing improved glucose levels and reductions in liver fat and cardiovascular risk compared to conventional LI.

The intensified LI led to a higher likelihood of normalizing glucose tolerance during a 3-year follow-up, suggesting that tailoring lifestyle interventions based on individual risk profiles can effectively prevent the progression to type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different Effects of Lifestyle Intervention in High- and Low-Risk Prediabetes: Results of the Randomized Controlled Prediabetes Lifestyle Intervention Study (PLIS). Fritsche, A., Wagner, R., Heni, M., et al.[2022]

Prediabetes is characterized by elevated blood glucose levels that are not high enough to be classified as diabetes, indicating a state of abnormal glucose homeostasis.

Recent evidence and the inclusion of prediabetes in ICD-10 codes support the idea that it is a distinct pathological condition associated with changes in various tissues and organs, highlighting its clinical significance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding prediabetes: definition, prevalence, burden and treatment options for an emerging disease. Rett, K., Gottwald-Hostalek, U.[2020]

Prediabetes is characterized by elevated blood glucose levels and is associated with an increased risk of developing diabetes, but not everyone with prediabetes will progress to diabetes, highlighting the importance of early identification and prevention measures.

Structured lifestyle interventions are the most effective strategy for managing prediabetes, and new research has identified high-risk subgroups within prediabetic populations, suggesting that targeted prevention strategies could be developed based on individual risk profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prediabetes as a therapeutic challenge in internal medicine]. Kantartzis, K., Fritsche, A., Birkenfeld, AL.[2023]

In a study of 48 patients with early diabetes mellitus type 2 (eDM2) and 16 with prediabetes (preDM), it was found that 14.6% of eDM2 patients had confirmed diabetic sensorimotor polyneuropathy (DSPN) based on nerve conduction studies, indicating a significant risk of neuropathy in early diabetes.

Using intraepidermal nerve fiber density (IENFD) as an additional diagnostic criterion revealed that 37.5% of eDM2 patients had DSPN, highlighting that neuropathy in preDM and eDM2 primarily affects sensory small fibers, which can be detected early with IENFD measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediabetes/early diabetes-associated neuropathy predominantly involves sensory small fibres. Divisova, S., Vlckova, E., Hnojcikova, M., et al.[2022]

In a study involving 44 participants (25 with normal fasting glucose and normal glucose tolerance, and 19 with normal fasting glucose but impaired glucose tolerance), insulin-stimulated glucose disposal was found to be significantly lower in those with impaired glucose tolerance, indicating a defect in insulin action.

The research concluded that the issues leading to impaired glucose tolerance are not due to defects in liver glucose production but rather due to impaired insulin action and β-cell function, highlighting the importance of insulin sensitivity in managing prediabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms Underlying the Pathogenesis of Isolated Impaired Glucose Tolerance in Humans. Varghese, RT., Dalla Man, C., Sharma, A., et al.[2018]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Treating prediabetes: why and how should we do it? [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Phenotyping the Prediabetic Population-A Closer Look at Intermediate Glucose Status and Cardiovascular Disease. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Successful treatment of prediabetes in clinical practice: targeting insulin resistance and β-cell dysfunction. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Vascular complications in prediabetes and type 2 diabetes: a continuous process arising from a common pathology. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Different Effects of Lifestyle Intervention in High- and Low-Risk Prediabetes: Results of the Randomized Controlled Prediabetes Lifestyle Intervention Study (PLIS). [2022]

6. England pubmed.ncbi.nlm.nih.gov

Understanding prediabetes: definition, prevalence, burden and treatment options for an emerging disease. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

[Prediabetes as a therapeutic challenge in internal medicine]. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Prediabetes/early diabetes-associated neuropathy predominantly involves sensory small fibres. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Mechanisms Underlying the Pathogenesis of Isolated Impaired Glucose Tolerance in Humans. [2018]