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mHealth + low-carb/ketogenic diet for Type 2 Diabetes

N/A
Waitlist Available
Led By Yan Du, PhD MPH RN
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 6 months
Awards & highlights

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
  • Cognitive Functioning
  • Weight Loss
  • Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Albumin-to-Creatinine ratio (ACR)
Estimated Glomerular Filtration rate (eGFR)
Gut Metabolomics
+2 more
Secondary outcome measures
Glycemic Control
Other outcome measures
Change in Blood Pressure
Fecal Metabolomics
Total blood lipids
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention Group (mHealth + low-carbohydrate/ketogenic diet group)Experimental Treatment1 Intervention
Total calories will be set according to Look AHEAD intervention, and carbohydrate consumption restriction will be set based on recommendations from American Diabetic Association, National Kidney Foundation, and other evidence-based resources. Participants in this group will be asked to consume a low-carb/ketogenic diet. Specially, participants will receive a carbohydrate, protein, and fat intake goal based on 1.5 : 1 ratio (1.5 grams of fat to 1 gram of carbohydrate and protein combined). Daily macronutrient and calorie consumption will be individualized for each participant using ideal body weight as inferred from wrist circumference and activity level. Carbohydrate consumption will be less than 10% (20~50 g), protein 10-20% (1.0~1.2g/kg ideal body weight), and fat 70-80% of total daily energy, respectively. Nutritional ketosis will be reached by consuming such diet (0.5 mmol/L).
Group II: Control Group (mHealth+low-fat diet group)Placebo Group1 Intervention
The low-fat group will be asked to restrict total calorie and total fat consumption according to the Look AHEAD intervention and MyPlate guidelines, with 26-44% carbs, 10-30% protein, and less than 30% fat.

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,369 Total Patients Enrolled
Yan Du, PhD MPH RNPrincipal InvestigatorUniversity of Texas Health San Antonio

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is registration open for this research endeavor?

"As per the clinicaltrials.gov database, this specific medical trial has now concluded its recruitment phase and is not seeking any further participants; though it was initially posted on June 3rd 2021 and last updated on July 1st 2022. Fortunately, there are more than 1500 other trials that require patients at present."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
65+
18 - 65
What site did they apply to?
UT Health San Antonio School of Nursing
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Metabolism of Low Carbohydrate and Ketogenic Diet
2021. "Metabolism of Low Carbohydrate and Ketogenic Diet". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05071287.
~11 spots leftby Apr 2025
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