AzTrials
AzTrials

Diabetes Mellitus Type 2 in ObeseNCT02668328

Cochlear-Vestibular Ganglion (CVG) in Newly Diagnosed Type 2 Diabetes Patients

A study testing Social Cognitive Theory Tailored Behavioral Intervention in people with Diabetes Mellitus Type 2 in Obese, run by NYU Langone Health.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

The proposed study is an integrative scientific undertaking, reflecting the input of experts in the behavioral sciences, mHealth technology, computational biology, endocrinology, biochemistry, and nutrition. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Diabetes Mellitus Type 2 in Obese
What is being tested?
Social Cognitive Theory Tailored Behavioral Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Sep 2016to Sep 2018
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 5 years or less since type 2 diabetes was diagnosed

Who cannot join

  • more 5 years since type 2 diabetes was diagnosed

About this study

Official title: CGV in Newly Diagnosed Type 2 Diabetes Patients: Effect of Dietary Interventions in the Human Microbiome

The proposed study is an integrative scientific undertaking, reflecting the input of experts in the behavioral sciences, mHealth technology, computational biology, endocrinology, biochemistry, and nutrition. The project features a unique translational approach, connecting behavior and biology in an economical manner that provides mechanistic insights into the progression of type 2 diabetes (T2D) and the biologic consequences of behavior change. The project may have profound implications for the clinical management of early T2D.

Read the detailed description

T2D poses a significant public health problem. Hyperglycemia is associated with a variety of vascular complications, but clinical trials of medication regimes designed to achieve near-normal HbA1c have been mostly negative. The lack of benefit observed in these trials may be due to the fact that they targeted HbA1c rather than glucose variability, and were conducted in patients with established T2D that had already experienced complications of the disease. In early T2D, management of postprandial glycemia may be particularly important for minimization of metabolic memory effects and preservation of beta cell function. Postprandial glycemia in early T2D is largely driven by dietary intake, but research findings that guide clinicians regarding the best dietary approach to prescribe are mixed. Studies done, to-date, have used one-size-fits-all dietary regimes that do not take into consideration the person's unique glycemic response to food. The investigators know from decades of research that behavioral methods are required to engage patients in lifestyle behavior change. The investigators argue that tailoring the approach to the participant's glycemic response and gut microbiome will enhance self-efficacy in ways that cannot be achieved through standard behavioral methods alone and, in turn, reduce glycemic variability and metabolic memory effects.

Co-PI Segal et al. demonstrated that subjects have high between-subject variability in postprandial response to the same food, suggesting that universal dietary recommendations are of limited utility for controlling elevated postprandial glucose. The machine learning algorithm devised by the group integrates multidimensional data to accurately predict personalized postprandial glycemic responses. In a subsequent validation study in 100 participants, they showed that a personally-tailored intervention based on the predicted response resulted in significantly improved postprandial glycemic response, and were accompanied by beneficial changes in gut microbiota.

Being tested
Social Cognitive Theory Tailored Behavioral Intervention

What participants receive

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

  • Social Cognitive Theory Tailored Behavioral InterventionBehavioural

    The intervention will enhance self-efficacy

Study groups in NCT02668328
Study groupRoleWhat they receive
Behavioral InterventionExperimentalThe proposed study involves a 2-phase randomized clinical trial in adults with recently diagnosed T2D. Participants will be randomized to a wait-list Control group, BI, or Tailored-BI. In Phase 1, wait-list Control participants will receive 6 months of standard care; BI and Tailored-BI participants will receive 6 months of Active Intervention. In Phase 2, wait-list Control group participants will cross-over to the delayed Tailored-BI, and the BI and Tailored-BI participants will enter a 6-month observation phase to examine maintenance effects of the intervention.
Receives: Behavioral: Social Cognitive Theory Tailored Behavioral Intervention

What is being measured

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

  1. Mean Amplitude of Glycemic Excursion (MAGE)

    Measured: 1 week

Timeline

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

  1. First posted29 Jan 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionFeb 2018 (estimated)
  4. Study completionSep 2018 (estimated)

Resources

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02668328
Sponsor's protocol ID
NYUmed
Status last verified
Oct 2016
First submitted
22 Dec 2015
Last updated
19 Oct 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Social Cognitive Theory Tailored Behavioral Intervention in people with Diabetes Mellitus Type 2 in Obese, run by NYU Langone Health.

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: withdrawn, as of the sponsor's last update on 19 Oct 2016. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Mean Amplitude of Glycemic Excursion (MAGE) (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 19 Oct 2016.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in