Pre-diabetesNCT05925933
High Protein Diet on Transcriptomic, Metabolomics, Hepatic and Pancreatic Fat Anatomy and Physiology in Asian Indians With Pre-diabetes
A study testing Intervention in people with Pre-diabetes, run by Diabetes Foundation, India.
Trial summary
Diabetes/ prediabetes is a substantial problem in India not only because it itself can be associated with morbidities such as coronary artery disease but also because it is a point of importance for the prevention of other diseases. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pre-diabetes
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 31 Oct 2026
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cases:
- Age 18 to 50 years. Subjects with pre-diabetes on oral glucose tolerance test (OGTT)
- Fasting blood glucose≥100mg/dl and <126 mg/dl or 2-h plasma glucose ≥140mg/dl and <200mg/dl (after ingestion of 75 grams of anhydrous oral glucose) or both.
- Controls:
- Age 18 to 50 years. Normoglycemia by OGTT
- Fasting blood glucose <100mg/dl and 2-h plasma glucose <140mg/dl (after ingestion of 75 gram of anhydrous oral glucose).
Who cannot join
- Acute infections and advanced end-organ damage.
- History of hepatitis or pancreatitis, abnormal liver and renal function tests.
- Recent (<3 months) changes in weight (≥5%) and/or weight changing medications.
- Subjects with metallic implants, pacemaker leads, radioactive seeds or surgical staples in the body.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of High Protein Diet on Transcriptomic Regulations, Plasma Metabolomics, Hepatic and Pancreatic Fat Anatomy and Physiology in Asian Indians With Pre-diabetes
Diabetes/ prediabetes is a substantial problem in India not only because it itself can be associated with morbidities such as coronary artery disease but also because it is a point of importance for the prevention of other diseases. It is not clear if a high protein calorie diet in the Indian population associated with a heightened tendency for prediabetes, metabolic syndrome, atherosclerosis and dysmetabolic state etc. could, besides lifestyle factors, be related to diet, or interaction between the two. The analysis of whole blood transcriptomes and plasma metabolomics profiles may be a potentially useful tool for the assessment of metabolic health status. The proposed study is the first to perform a detailed gene expression profiling with the use of next-generation sequencing technology to assess the differences in molecular mechanisms in the peripheral blood of subjects with prediabetes.
Read the detailed description
This study will be conducted at the outpatient department of the National Diabetes, Obesity and Cholesterol Foundation (N-DOC), Diabetes Foundation (India) (DFI)and Fortis-C-DOC, Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology, New Delhi, India.
Experimental Protocol: In this study, a total of 60 subjects with pre-diabetes and 60 age and body mass index, and gender-matched controls (age 18-40 years) will be recruited. They will be randomized to an equicaloric normal diet (carbohydrates 60%, protein 15%, and fat 25%) or a high protein diet (carbohydrates 45%, protein 29%, and fat 26%) over 8-week periods. All assessments as done on day 1 will be repeated at day 60.
- Conditions
- Pre-diabetes
- Being tested
- Intervention
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
high protein diet (carbohydrates 45%, protein 29%, and fat 26%) over 8-week periods.
| Study group | Role | What they receive |
|---|---|---|
| High Protein Diet | Experimental | High protein diet (carbohydrates 45%, protein 29%, and fat 26%) over 8-week periods. All assessments as done on day 1 will be repeated on day 60. Receives: Other: Intervention |
| Control Group | Other | Equicaloric normal diet (carbohydrates 60%, protein 15%, and fat 25%) Receives: Other: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
BMI will be calculated by using formula weight (Kg)/height (m2).
Measured: 6 Months
Body Fat
Body estimations will be done by DEXA Scan
Measured: 2 MONTHS
Liver Fat
Liver fat will be done by MRI Scan
Measured: 2 Months
Next Generation sequencing
Measured: 06 MONTHS
Pancreatic fat
Pancreatic fat estimation will be done by MRI
Measured: 06 MONTHS
RNA Extraction
Measured: 06 MONTHS
Metabolomics profile
Measured: 06 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Oct 2023 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diabetes Foundation, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925933
- Sponsor's protocol ID
- DFI/DST/2023
- Status last verified
- Jun 2023
- First submitted
- 13 Jun 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In this study a total of 60 subjects with pre-diabetes and 60 age and body mass index, and gender matched controls (age 18-40 years) will be recruited. They will be randomized to an equicaloric normal diet or high protein diet over 8-week periods. All assessments as done on day 1 will be repeated on day 60.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Protein Diet on Transcriptomic Regulations, Plasma Metabolomics, Hepatic and Pancreatic Fat Anatomy and Physiology in Asian Indians With Pre-diabetes
- ClinicalTrials.gov ID
- NCT05925933
- Acronym / sponsor ID
- DFI/DST/2023
- Conditions
- Pre-diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Diabetes Foundation, IndiaUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 29 Jun 2023 (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.
Diabetes/ prediabetes is a substantial problem in India not only because it itself can be associated with morbidities such as coronary artery disease but also because it is a point of importance for the prevention of other diseases. It is not clear if a high protein calorie diet in the Indian population associated with a heightened tendency for prediabetes, metabolic syndrome, atherosclerosis and dysmetabolic state etc. could, besides lifestyle factors, be related to diet, or interaction between the two. The analysis of whole blood transcriptomes and plasma metabolomics profiles may be a potentially useful tool for the assessment of metabolic health status. The proposed study is the first to perform a detailed gene expression profiling with the use of next-generation sequencing technology to assess the differences in molecular mechanisms in the peripheral blood of subjects with prediabetes.
Detailed description
This study will be conducted at the outpatient department of the National Diabetes, Obesity and Cholesterol Foundation (N-DOC), Diabetes Foundation (India) (DFI)and Fortis-C-DOC, Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology, New Delhi, India.
Experimental Protocol: In this study, a total of 60 subjects with pre-diabetes and 60 age and body mass index, and gender-matched controls (age 18-40 years) will be recruited. They will be randomized to an equicaloric normal diet (carbohydrates 60%, protein 15%, and fat 25%) or a high protein diet (carbohydrates 45%, protein 29%, and fat 26%) over 8-week periods. All assessments as done on day 1 will be repeated at day 60.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Protein Diet | Experimental | Other: InterventionHigh protein diet (carbohydrates 45%, protein 29%, and fat 26%) over 8-week periods. All assessments as done on day 1 will be repeated on day 60. |
| Control Group | Other | Other: InterventionEquicaloric normal diet (carbohydrates 60%, protein 15%, and fat 25%) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 to 50 years. Subjects with pre-diabetes on oral glucose tolerance test (OGTT)
- Fasting blood glucose≥100mg/dl and <126 mg/dl or 2-h plasma glucose ≥140mg/dl and <200mg/dl (after ingestion of 75 grams of anhydrous oral glucose) or both.
- Age 18 to 50 years. Normoglycemia by OGTT
- Fasting blood glucose <100mg/dl and 2-h plasma glucose <140mg/dl (after ingestion of 75 gram of anhydrous oral glucose).
Key exclusion criteria (4 listed)
- Acute infections and advanced end-organ damage.
- History of hepatitis or pancreatitis, abnormal liver and renal function tests.
- Recent (<3 months) changes in weight (≥5%) and/or weight changing medications.
- Subjects with metallic implants, pacemaker leads, radioactive seeds or surgical staples in the body.
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 |
|---|---|---|
| Interventionhigh protein diet (carbohydrates 45%, protein 29%, and fat 26%) over 8-week periods. | Other | Control Group, High Protein Diet |
Primary outcome
Body Mass Index
Time frame: 6 Months
BMI will be calculated by using formula weight (Kg)/height (m2).
Body Fat
Time frame: 2 MONTHS
Body estimations will be done by DEXA Scan
Liver Fat
Time frame: 2 Months
Liver fat will be done by MRI Scan
Next Generation sequencing
Time frame: 06 MONTHS
Pancreatic fat
Time frame: 06 MONTHS
Pancreatic fat estimation will be done by MRI
RNA Extraction
Time frame: 06 MONTHS
Metabolomics profile
Time frame: 06 MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Individual participant dataSharing planned: No. In this study a total of 60 subjects with pre-diabetes and 60 age and body mass index, and gender matched controls (age 18-40 years) will be recruited. They will be randomized to an equicaloric normal diet or high protein diet over 8-week periods. All assessments as done on day 1 will be repeated on day 60.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Pre-diabetes, run by Diabetes Foundation, India.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anoop Misra, MD (01149101222, anoopmisra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (time frame: 6 Months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2023.