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

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.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes Mellitus Type 2 in Obese
• Intervention / Treatment: Behavioral: Social Cognitive Theory Tailored Behavioral Intervention

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 5 years or less since type 2 diabetes was diagnosed

Exclusion Criteria:

• more 5 years since type 2 diabetes was diagnosed

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Behavioral Intervention; The 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.

Behavioral: Social Cognitive Theory Tailored Behavioral Intervention; The intervention will enhance self-efficacy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Amplitude of Glycemic Excursion (MAGE)	1 week

Collaborators and Investigators

• Sponsor: NYU Langone Health

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: December 22, 2015
• First Submitted That Met QC Criteria: January 26, 2016
• First Posted (Estimate): January 29, 2016

Study Record Updates

• Last Update Posted (Estimate): October 19, 2016
• Last Update Submitted That Met QC Criteria: October 18, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NYUmed