Diabetes Prevention and Education

NCT05769127 | Withdrawn

• 1 other identifier: HP-00102730
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 diabetes mellitus is one of the fastest growing public health problems in developed and developing countries and imposes a large financial burden on health-care systems. Preventing, delaying, and managing diabetes should be a priority for health-care systems. Nationally, 38% of adults have prediabetes, with more than 80% of people with prediabetes being unaware of their condition. In Maryland, an estimated 10.5% of adults report prediabetes, and 33.7% of Baltimore City residents have obesity, an important risk factor for prediabetes. The BMDRP aims to increase the capacity of BMDRP hospitals and community partners to offer DPP and DSMT directly in communities and will also increase the number of referrals into these programs. Successful enrollment and completion of DPP has demonstrated reduced risk of developing type 2 diabetes for individuals with pre-diabetes. However, limited data exist on changes in body composition and liver fat in individuals completing DPP. Individuals with pre-diabetes often have obesity and non-alcoholic fatty liver disease. We will evaluate for changes in body fat and liver fat in individuals completing the DPP program.

Conditions

Diabetes; Pre Diabetes; Fatty Liver; Body Weight Changes

Outcome Measures

Primary Outcomes (2)

• Enrollees into DPP and DSMT

  Measure enrolled participants in DPP or DSMT programs

  end of calendar year enrollment, yearly for 3 years

• Change in body weight for DPP participants

  Change in weight from baseline to 12 months after participating in DPP lifestyle intervention

  12 months

Secondary Outcomes (3)

• Change in diabetes control for DSMT participants

  12 months

• change in body composition in DPP participants

  12 months

• change in liver elastography in DPP participants

  12 months

Study Arms (1)

Intervention

EXPERIMENTAL

All subjects participating in the diabetes prevention program will be offered body composition analysis and liver fat analysis, before, during, and after the lifestyle intervention

Other: Diabetes Prevention Program (DPP), Diabetes Self-Management Training (DSMT)

Interventions

Diabetes Prevention Program (DPP), Diabetes Self-Management Training (DSMT) OTHER

DPP lifestyle intervention program DSMT education on diabetes and lifestyle changes

Intervention

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Qualify for DPP with a diagnosis of pre-diabetes and elevated BMI (≥25 kg/m2 , ≥23kg/m2 if Asian)
• For DSMT, individuals with type 2 diabetes

You may not qualify if:

• \- Normoglycemia

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Center for Diabetes and Endocrinology

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Intolerance; Fatty Liver; Body Weight Changes

Interventions

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Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Liver Diseases; Digestive System Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 15, 2023
• Study Start: April 26, 2023
• Primary Completion: June 10, 2025
• Study Completion: June 10, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)