Diabetic Kidney DiseaseNCT05071287
Metabolism of Low Carbohydrate and Ketogenic Diet
A study testing mHealth + low-fat diet and mHealth + low-carb/ketogenic diet in people with Diabetic Kidney Disease and Cognitive Function, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
Trial summary
This study will assess the preliminary efficacy of a lifestyle intervention including low-carb/ketogenic diet and exercise, enhanced by self-monitoring through health technologies on weight and diabetes outcomes (Glucose, HbA1c) and diabetic complications (cognitive function, and renal function) in a 6-month… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Kidney Disease, Cognitive Function, Weight Loss
- What is being tested?
- mHealth + low-fat diet and mHealth + low-carb/ketogenic diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jun 2021to 11 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to participate in the study
- being 18 and over
- For overweight/obese adults (BMI≥25kg/m2)
- without self-reported diagnosis of Type 2 Diabetes (T2D) or Chronic Kidney Disease (CKD): Estimated Glomerular Filtration Rate (eGFR)≥90mL/min/1.73m2 and urine albumin to creatinine ratio (ACR)<30mg/g within the past 12 months
- with Type 2 Diabetes (T2D) but without Chronic Kidney Disease (CKD): Estimated glomerular filtration rate (eGFR)≥90mL/min/1.73m2 and Albumin-to-Creatinine ratio (ACR)<30mg/g within the past 12 months
- with early stage Chronic Kidney Disease (CKD): 60≤eGFR<90mL/min/1.73m2 or 30mg/g ≤ACR< 1000mg/g within the 12 months
Show all 9Show fewer
- can speak and understand English
- own a smart phone or tablet that has reliable internet/data access
- agree to comply with all study requirements
Who cannot join
- Patients with triglyceride ≥ 500 mg/dL or with Low-Density Lipoprotein Cholesterol≥ 129mg/dL
- type 1 diabetes (by self-report)
- severe psychiatric disorders deemed by investigators, which might interfere with study procedures (by self-report)
- severe chronic conditions (e.g. severe heart disease, renal disease, cognitive impairment, etc.) that would preclude them from participating
- unwillingness to sign the consent form and be randomized into a study group
- enrollment in other low carb/keto diet or weight loss programs
Show all 10Show fewer
- inability to walk without assistance (by self-report)
- under SGLT2 inhibitor treatment
- being pregnant or breast feeding (by self-report)
- having plans to leave the city or USA for over 2 weeks within 6 months at enrollment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Health System Texas Diabetic Institute
San Antonio, Texas, 78207
UT Health San Antonio School of Nursing
San Antonio, Texas, 78229
About this study
Official title: Precision Metabolic Mechanisms of Low Carbohydrate and Ketogenic Diet
This study will assess the preliminary efficacy of a lifestyle intervention including low-carb/ketogenic diet and exercise, enhanced by self-monitoring through health technologies on weight and diabetes outcomes (Glucose, HbA1c) and diabetic complications (cognitive function, and renal function) in a 6-month randomized clinical trial in 60 overweight/obese adults with or without T2D. Renal function will be assessed via both traditional and novel biomarkers, including novel metabolites and mitochondrial function.
Read the detailed description
Participants in both groups will receive standardized health education sessions including lifestyle management, blood glucose control, blood pressure control, and prevention of diabetic complications from trained providers who are also investigators of this study. The lifestyle intervention from the evidence-based Group Lifestyle Balance (GLB) program (http://www.diabetesprevention.pitt.edu/index.php/for-the-public/for-health-providers/group-lifestyle-balance-curriculum/) and Look AHEAD intervention (https://www.lookaheadtrial.org) will be modified for this study. Goal for weight loss and physical activity will be set for each participant based on recommendations from GLB and Look AHEAD. Lifestyle intervention will be delivered through interactive digital lessons. Smart phone and mobile health devices will be used for each participant to self-monitor diet, physical activity, weight, glucose level, blood pressure, and blood ketone (if randomized to the low-car/ketogenic diet group).
Control group (mHealth+ low-fat diet group):
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.
Intervention group (mHealth+ low-carb/ketogenic diet group):
The low-carb/ketogenic diet group, will have total calorie set according to Look AHEAD intervention, and carb 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).
All diet intervention materials will be developed by a registered dietitian according to the evidence-based guidelines. The dietitian will also be responsible to any study activities relevant to diet. These activities include but are not limited to responding to some specific diet questions to study participants and health related measurements relevant to diet changes.
An interventionist, under supervision of a registered dietitian, will interact with each participant from both groups at the beginning of the intervention as an introduction visit, and three individual intervention sessions at month 1, 3, and 5. During the introduction visit, the interventionist will set up a personalized weight loss goal and caloric intake goal with the participants. The individual intervention sessions at month 1, 3 and 5 will be arranged to solve the encountered problems regarding diet, weight loss, caloric intake and action planning.
Additional communication through phone call will be used to support patient dietary changes throughout the study based on their self-monitoring information.
- Conditions
- Diabetic Kidney Disease, Cognitive Function, Weight Loss, Diabetic Control, Type2 Diabetes
- Being tested
- mHealth + low-fat diet, mHealth + low-carb/ketogenic diet
- Keywords
- Weight loss, Healthy lifestyle intervention, Type 2 Diabetes, Renal function
- Medical subject headings
- Diabetic Nephropathies, Weight Loss, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth + low-fat dietOther
A restricted total calorie and reduced total fat consumption.
mHealth + low-carb/ketogenic dietOther
A low-carb/ketogenic diet
| Study group | Role | What they receive |
|---|---|---|
| Control Group (mHealth+low-fat diet group) | Placebo comparator | 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. Receives: Other: mHealth + low-fat diet |
| Intervention Group (mHealth + low-carbohydrate/ketogenic diet group) | Experimental | 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). Receives: Other: mHealth + low-carb/ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measure of weight change that occurred while assigned to the diet
Measured: Baseline to 6 months
Secondary outcomes (8)
BMI
BMI (Body Mass Index) is a numerical value derived from a person's weight and height, used as a screening tool to classify individuals into weight categories. It is calculated using weight (kg) divided by height (m)2.
Measured: Baseline to 6 months
HbA1c
HbA1c (Hemoglobin A1c) is a blood test that measures the average blood glucose levels over the past 2 to 3 months.
Measured: Baseline to 6 months
Blood pressure
Blood Pressure (BP) is the force exerted by circulating blood against the walls of the arteries. It is measured in millimeters of mercury (mmHg) and recorded as two values: Systolic Pressure and Diastolic Pressure.
Measured: Baseline to 6 months
Blood lipids
Blood lipids refer to the fatty substances found in the bloodstream, including cholesterol and triglycerides.
Measured: Baseline to 6 months
Estimated Glomerular Filtration rate (eGFR)
Measure of change in eGFR in a blood sample.
Measured: Baseline to 6 months
Albumin-to-Creatinine ratio (ACR)
Measure of the change in ACR in urine.
Measured: Baseline to 6 months
Metabolites
Metabolites are small molecules that are intermediates or end products of metabolism.
Measured: Baseline to 6 months
Mitochondrial DNA
Measure of change of mitochondrial function using blood and urine levels
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start3 Jun 2021
- Primary completion30 Apr 2022
- Study completion11 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with 2 arms. Randomization will be done in clusters: 1. overweight/obese adults with type 2 diabetes (T2D) but no chronic kidney disease (CKD) 2. overweight/obese with T2D without CKD 3. overweight/obese with early stage CKD
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Du, PhD MPH RN, Principal investigator, University of Texas Health San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05071287
- Sponsor's protocol ID
- HSC20190528H
- Status last verified
- Feb 2025
- First submitted
- 24 Aug 2021
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan to make Individual Participant Data (IPD) available to other researchers has not been decided.
Publications
Li S, Du Y, Miao H, Sharma K, Li C, Yin Z, Brimhall B, Wang J. Understanding Heterogeneity in Individual Responses to Digital Lifestyle Intervention Through Self-Monitoring Adherence Trajectories in Adults With Overweight or Obesity: Secondary Analysis of a 6-Month Randomized Controlled Trial. J Med Internet Res. 2024 Mar 20;26:e53294. doi: 10.2196/53294.
PubMed 38506903Li S, Du Y, Meireles C, Song D, Sharma K, Yin Z, Brimhall B, Wang J. Decoding Heterogeneity in Data-Driven Self-Monitoring Adherence Trajectories in Digital Lifestyle Interventions for Weight Loss: A Qualitative Study. Res Sq [Preprint]. 2024 Jan 19:rs.3.rs-3854650. doi: 10.21203/rs.3.rs-3854650/v1.
PubMed 38313251
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Metabolic Mechanisms of Low Carbohydrate and Ketogenic Diet
- ClinicalTrials.gov ID
- NCT05071287
- Acronym / sponsor ID
- HSC20190528H
- Conditions
- Diabetic Kidney Disease, Cognitive Function, Weight Loss, Diabetic Control, Type2 Diabetes
- Keywords
- Weight loss, Healthy lifestyle intervention, Type 2 Diabetes, Renal function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the preliminary efficacy of a lifestyle intervention including low-carb/ketogenic diet and exercise, enhanced by self-monitoring through health technologies on weight and diabetes outcomes (Glucose, HbA1c) and diabetic complications (cognitive function, and renal function) in a 6-month randomized clinical trial in 60 overweight/obese adults with or without T2D. Renal function will be assessed via both traditional and novel biomarkers, including novel metabolites and mitochondrial function.
Detailed description
Participants in both groups will receive standardized health education sessions including lifestyle management, blood glucose control, blood pressure control, and prevention of diabetic complications from trained providers who are also investigators of this study. The lifestyle intervention from the evidence-based Group Lifestyle Balance (GLB) program (http://www.diabetesprevention.pitt.edu/index.php/for-the-public/for-health-providers/group-lifestyle-balance-curriculum/) and Look AHEAD intervention (https://www.lookaheadtrial.org) will be modified for this study. Goal for weight loss and physical activity will be set for each participant based on recommendations from GLB and Look AHEAD. Lifestyle intervention will be delivered through interactive digital lessons. Smart phone and mobile health devices will be used for each participant to self-monitor diet, physical activity, weight, glucose level, blood pressure, and blood ketone (if randomized to the low-car/ketogenic diet group).
Control group (mHealth+ low-fat diet group):
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.
Intervention group (mHealth+ low-carb/ketogenic diet group):
The low-carb/ketogenic diet group, will have total calorie set according to Look AHEAD intervention, and carb 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).
All diet intervention materials will be developed by a registered dietitian according to the evidence-based guidelines. The dietitian will also be responsible to any study activities relevant to diet. These activities include but are not limited to responding to some specific diet questions to study participants and health related measurements relevant to diet changes.
An interventionist, under supervision of a registered dietitian, will interact with each participant from both groups at the beginning of the intervention as an introduction visit, and three individual intervention sessions at month 1, 3, and 5. During the introduction visit, the interventionist will set up a personalized weight loss goal and caloric intake goal with the participants. The individual intervention sessions at month 1, 3 and 5 will be arranged to solve the encountered problems regarding diet, weight loss, caloric intake and action planning.
Additional communication through phone call will be used to support patient dietary changes throughout the study based on their self-monitoring information.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial with 2 arms. Randomization will be done in clusters: 1. overweight/obese adults with type 2 diabetes (T2D) but no chronic kidney disease (CKD) 2. overweight/obese with T2D without CKD 3. overweight/obese with early stage CKD
| Arm | Type | Receives |
|---|---|---|
| Control Group (mHealth+low-fat diet group) | Placebo comparator | Other: mHealth + low-fat dietThe 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. |
| Intervention Group (mHealth + low-carbohydrate/ketogenic diet group) | Experimental | Other: mHealth + low-carb/ketogenic dietTotal 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Willing to participate in the study
- being 18 and over
- For overweight/obese adults (BMI≥25kg/m2)
- can speak and understand English
- own a smart phone or tablet that has reliable internet/data access
Key exclusion criteria (10 listed)
- Patients with triglyceride ≥ 500 mg/dL or with Low-Density Lipoprotein Cholesterol≥ 129mg/dL
- type 1 diabetes (by self-report)
- severe psychiatric disorders deemed by investigators, which might interfere with study procedures (by self-report)
- severe chronic conditions (e.g. severe heart disease, renal disease, cognitive impairment, etc.) that would preclude them from participating
- unwillingness to sign the consent form and be randomized into a study group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth + low-fat dietA restricted total calorie and reduced total fat consumption. | Other | Control Group (mHealth+low-fat diet group) |
| mHealth + low-carb/ketogenic dietA low-carb/ketogenic diet | Other | Intervention Group (mHealth + low-carbohydrate/ketogenic diet group) |
Primary outcome
Weight
Time frame: Baseline to 6 months
Measure of weight change that occurred while assigned to the diet
8 secondary outcomes
BMI
Time frame: Baseline to 6 months
HbA1c
Time frame: Baseline to 6 months
Blood pressure
Time frame: Baseline to 6 months
Blood lipids
Time frame: Baseline to 6 months
Estimated Glomerular Filtration rate (eGFR)
Time frame: Baseline to 6 months
Albumin-to-Creatinine ratio (ACR)
Time frame: Baseline to 6 months
Metabolites
Time frame: Baseline to 6 months
Mitochondrial DNA
Time frame: Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Derived from this study: PubMed 38506903Li S, Du Y, Miao H, Sharma K, Li C, Yin Z, Brimhall B, Wang J. Understanding Heterogeneity in Individual Responses to Digital Lifestyle Intervention Through Self-Monitoring Adherence Trajectories in Adults With Overweight or Obesity: Secondary Analysis of a 6-Month Randomized Controlled Trial. J Med Internet Res. 2024 Mar 20;26:e53294. doi: 10.2196/53294.
- Derived from this study: PubMed 38313251Li S, Du Y, Meireles C, Song D, Sharma K, Yin Z, Brimhall B, Wang J. Decoding Heterogeneity in Data-Driven Self-Monitoring Adherence Trajectories in Digital Lifestyle Interventions for Weight Loss: A Qualitative Study. Res Sq [Preprint]. 2024 Jan 19:rs.3.rs-3854650. doi: 10.21203/rs.3.rs-3854650/v1.
- Individual participant dataSharing planned: Undecided. The plan to make Individual Participant Data (IPD) available to other researchers has not been decided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Du, PhD MPH RN principal investigator
University of Texas Health San Antonio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth + low-fat diet and mHealth + low-carb/ketogenic diet in people with Diabetic Kidney Disease and Cognitive Function, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05071287, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.