Study Summary
This trial will test a lifestyle intervention including diet and exercise, enhanced by self-monitoring health technologies, on weight and diabetes outcomes and diabetic complications in 60 overweight/obese adults with or without T2D. Renal function will be assessed using traditional and novel biomarkers, including novel metabolites and mitochondrial function.
Eligible Conditions
- Type 2 Diabetes
- Diabetic Kidney Disease
- Diabetes Control
- Weight Loss
- Cognitive Functioning
Treatment Effectiveness
Effectiveness Progress
Study Objectives
5 Primary · 1 Secondary · Reporting Duration: Baseline to 6 months
Baseline to 6 months
Albumin-to-Creatinine ratio (ACR)
Change in Blood Pressure
Estimated Glomerular Filtration rate (eGFR)
Fecal Metabolomics
Glycemic Control
Gut Metabolomics
Mitochondrial DNA
Montreal Cognitive Assessment (MoCA)
Total blood lipids
Weight Change
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Intervention Group (mHealth + low-carbohydrate/ketogenic diet group)
1 of 2
Control Group (mHealth+low-fat diet group)
1 of 2
Experimental Treatment
Non-Treatment Group
60 Total Participants · 2 Treatment Groups
Primary Treatment: mHealth + low-carb/ketogenic diet · Has Placebo Group · N/A
Intervention Group (mHealth + low-carbohydrate/ketogenic diet group)
Other
Experimental Group · 1 Intervention: mHealth + low-carb/ketogenic diet · Intervention Types: OtherControl Group (mHealth+low-fat diet group)
Other
PlaceboComparator Group · 1 Intervention: mHealth + low-fat diet · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 6 months
Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
399 Previous Clinical Trials
73,665 Total Patients Enrolled
Yan Du, PhD MPH RNPrincipal InvestigatorUniversity of Texas Health San Antonio
Eligibility Criteria
Age 18+ · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have no self-reported diagnosis of Type 2 Diabetes (T2D) or Chronic Kidney Disease (CKD) and an estimated glomerular filtration rate (eGFR)≥90mL/min/1.
You are overweight or obese.
You are willing to participate in the study.
You have Type 2 Diabetes (T2D) but without Chronic Kidney Disease (CKD)
You own a smart phone or tablet that has reliable internet/data access.
Who else is applying?
What state do they live in?
| Texas | 100.0% |
How old are they?
| 65+ | 50.0% |
| 18 - 65 | 50.0% |
What site did they apply to?
| UT Health San Antonio School of Nursing | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 87.5% |
| Did not meet criteria | 12.5% |
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