Print

Lay Description

This study is to assess the effects of a lifestyle intervention including low-carb/ketogenic diet and exercise, enhanced by self-monitoring and individualized feedback through health technologies on renal function in overweight or obese T2D patients with early stage diabetic kidney disease (DKD) or without DKD.

Category

  • Diabetes
  • Nutrition
IRB Number
20190528HU
NCT Number
ct.gov registration not required
Open to Enrollment
No

Eligibility

Eligible Ages
Between 18 and 70
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

​​​​​​​Overweight/obese adults without type 2 diabetes (T2D) or chronic kidney disease (CKD)

1) willing to participate in the study

2) aged 18 and over

3) obese or overweight (BMI≥25kg/m2)

4) no self-reported diagnosis of T2D

5) no evidence of CKD (eGFR≥90mL/min/1.73m2 and urine albumin to creatinine ratio (ACR)<30mg/g within the past 12 months);

6) can speak and understand English

7) own a smart phone or tablet that has reliable internet/data access

8) agree to comply with all study requirements.


Overweight/obese adults with type 2 diabetes (T2D) and without chronic kidney disease (CKD)

1) willing to participate in the study

2) aged 18 and over

3) obese or overweight (BMI≥25kg/m2)

4) self-reported diagnosis of T2D

5) no self-reported evidence of CKD (eGFR≥90mL/min/1.73m2 and urine albumin to creatinine ratio (ACR)<30mg/g within the past 12 months);

6) can speak and understand English

7) own a smart phone or tablet that has reliable internet/data access

8) agree to comply with all study requirements.


Overweight/obese adults with type 2 diabetes (T2D) and chronic kidney disease (CKD)

1) willing to participate in the study

2) aged 18 and over

3) obese or overweight (BMI≥25kg/m2)

4) self-reported diagnosis of T2D

5) present evidence of CKD (60≤eGFR<90mL/min/1.73m2 and or 30mg/g ≤ACR< 1000mg/g within the past 12 months);

6) can speak and understand English

7) own a smart phone or tablet that has reliable internet/data access

8) agree to comply with all study requirements.

Exclusion Criteria

1) having plans to leave the city or USA over 2 weeks within 6 months at enrollment

2) severe chronic conditions (e.g. severe heart disease, renal disease, cognitive impairment, etc.) that would preclude them from participating

3) sever psychiatric disorders deemed by investigators, which might interfere with study procedures (by self-report)

3) unwillingness to sign the consent form and be randomized into a study group

4) enrollment in other weight loss programs or low-carb/ketogenic diet programs

5) inability to walk without assistance (by self-report)

6) being pregnant or breast feeding (by self-report)

7) self-reported diagnosis of type 1 diabetes

8) triglyceride ≥ 500 mg/dL or Low-Density Lipoprotein Cholesterol≥ 129mg/dL

10) under SGLT2 inhibitor treatment

Study Design

Arm Groups

Study Contact


Regulatory Point of Contact
Yan Du
(210) 567-2170
duy@uthscsa.edu

Regulatory Point of Contact
Shiyu Li
(210) 567-5800
lis9@uthscsa.edu

Regulatory Point of Contact
Jing Wang
(210) 450-8561
wangj1@uthscsa.edu

Local Recruitment Point of Contact
Shiyu Li
(210) 567-5800
lis9@uthscsa.edu

Local Recruitment Point of Contact
Jing Wang
(210) 450-8561
wangj1@uthscsa.edu

Principal Investigator
Yan Du