Type 2 Diabetes Mellitus in ObeseNCT04363710
Prospective Interventional Study on Reversibility of Type 2 Diabetes Mellitus With Hypocaloric Diet
A study testing Low Calorie Diet in people with Type 2 Diabetes Mellitus in Obese, run by Max Healthcare Insititute Limited at 1 site in India.
Trial summary
T2DM, a chronic progressive disorder has an epidemic status in India. Remission (HbA1c of < 6.5% without any anti-diabetic medication) of T2DM is achievable with diet modifications in recently diagnosed obese T2D individuals. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Type 2 Diabetes Mellitus in Obese
- What is being tested?
- Low Calorie Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteIndia
- Study dates
- 31 May 2017to 7 Nov 2018
- 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with BMI ≥ 30 kg/m^2
- DM history of less than 6 years.
- HBA1C of 6.5-8.5 %.
- On two or less than two diabetes medication.
Who cannot join
- Patients on Insulin
- Patients having any co morbidity like severe diabetic nephropathy, neuropathy and any other serious illness.
- Evidence of Type 1 diabetes, ketones and acidosis.
Trial locations and contacts
1 site in 1 country.
India1 site
Max Healthcare
New Delhi, National Capital Territory of Delhi, 110017
About this study
T2DM, a chronic progressive disorder has an epidemic status in India. Remission (HbA1c of < 6.5% without any anti-diabetic medication) of T2DM is achievable with diet modifications in recently diagnosed obese T2D individuals. Studies suggest Very Low Calorie Diet (600 - 800kcal) and Low Calorie Diet-LCD (800 -1000 kcal) using Meal replacers (MR) are helpful. The investigators aimed to study the effects of LCD without any anti diabetic medication in intervention group and later comparing it with Control group (on standard medical treatment).
Read the detailed description
The objective is to study the effect of LCD in anthropometric , biochemical and NAFLD (Non Alcholic Fatty Liver Disease) parameters after 8 weeks and 24 weeks from enrollment.
Purposive sampling is used to enroll participants in the study. The LCD is a combination of one meal replacer and modified major meals. Calculated exchanges of food groups is taken care of in the other two major meals and snacks in between. Inorder to adhere compliance clinical (at baseline, after 8 weeks, after 24 weeks) as well as virtual visits through whatsapp, e-mails, SMS, phone calls (once a week during 8 weeks of intervention and further once a month upto 24 weeks) are scheduled. After 8 weeks of LCD, calorie is increased to 1200-1400 Kcal/day. In the control group the standard medical treatment is continued.
The data is collected in case report form and analysed using SPSS software by statistician.
- Conditions
- Type 2 Diabetes Mellitus in Obese
- Being tested
- Low Calorie Diet
- Keywords
- Type 2 Diabetes Mellitus, Low Calorie Diet, Meal Replacer
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Calorie DietOther
800-1000 Kcal/day
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants in this arm were advised intervention of Low Calorie Diet (800-1000 Kcal/day) for 8 weeks without any anti diabetic medication Receives: Other: Low Calorie Diet |
| Control Group | No intervention | Participants in this arm were kept on their standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c in percentage
To bring HbA1c below diagnostic criteria of type 2 diabetes mellitus as per ADA 2020
Measured: up to 24 weeks
Fasting Blood Glucose in millimoles per liter and Fasting Insulin Level in picomole per liter will be combined to report HOMA IR
To achieve normal HOMA IR range
Measured: up to 24 weeks
Weight in kilogram and height in meters will be combined to report BMI in Kg/m^2
when obese T2D individuals will have significant improvement in BMI
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start31 May 2017
- Primary completion1 Jun 2018
- Study completion7 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus in ObeseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max Healthcare Insititute Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sujeet Jha, MRCP, Principal investigator, Prinicipal Director, Institute of Endocrinology & Metabolism, Maxhealthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363710
- Sponsor's protocol ID
- RT2DM20
- Status last verified
- Apr 2020
- First submitted
- 13 Apr 2020
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Interventional Study on Reversibility of Type 2 Diabetes Mellitus With Hypocaloric Diet
- ClinicalTrials.gov ID
- NCT04363710
- Acronym / sponsor ID
- RT2DM20
- Conditions
- Type 2 Diabetes Mellitus in Obese
- Keywords
- Type 2 Diabetes Mellitus, Low Calorie Diet, Meal Replacer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Max Healthcare Insititute LimitedUniversity, hospital or other
- Study start
- 31 May 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 7 Nov 2018 (actual)
- First posted
- 27 Apr 2020 (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.
T2DM, a chronic progressive disorder has an epidemic status in India. Remission (HbA1c of < 6.5% without any anti-diabetic medication) of T2DM is achievable with diet modifications in recently diagnosed obese T2D individuals. Studies suggest Very Low Calorie Diet (600 - 800kcal) and Low Calorie Diet-LCD (800 -1000 kcal) using Meal replacers (MR) are helpful. The investigators aimed to study the effects of LCD without any anti diabetic medication in intervention group and later comparing it with Control group (on standard medical treatment).
Detailed description
The objective is to study the effect of LCD in anthropometric , biochemical and NAFLD (Non Alcholic Fatty Liver Disease) parameters after 8 weeks and 24 weeks from enrollment.
Purposive sampling is used to enroll participants in the study. The LCD is a combination of one meal replacer and modified major meals. Calculated exchanges of food groups is taken care of in the other two major meals and snacks in between. Inorder to adhere compliance clinical (at baseline, after 8 weeks, after 24 weeks) as well as virtual visits through whatsapp, e-mails, SMS, phone calls (once a week during 8 weeks of intervention and further once a month upto 24 weeks) are scheduled. After 8 weeks of LCD, calorie is increased to 1200-1400 Kcal/day. In the control group the standard medical treatment is continued.
The data is collected in case report form and analysed using SPSS software by statistician.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Low Calorie DietParticipants in this arm were advised intervention of Low Calorie Diet (800-1000 Kcal/day) for 8 weeks without any anti diabetic medication |
| Control Group | No intervention | –Participants in this arm were kept on their standard medical treatment |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with BMI ≥ 30 kg/m^2
- DM history of less than 6 years.
- HBA1C of 6.5-8.5 %.
- On two or less than two diabetes medication.
Key exclusion criteria (3 listed)
- Patients on Insulin
- Patients having any co morbidity like severe diabetic nephropathy, neuropathy and any other serious illness.
- Evidence of Type 1 diabetes, ketones and acidosis.
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 |
|---|---|---|
| Low Calorie Diet800-1000 Kcal/day | Other | Intervention group |
Primary outcome
HbA1c in percentage
Time frame: up to 24 weeks
To bring HbA1c below diagnostic criteria of type 2 diabetes mellitus as per ADA 2020
Fasting Blood Glucose in millimoles per liter and Fasting Insulin Level in picomole per liter will be combined to report HOMA IR
Time frame: up to 24 weeks
To achieve normal HOMA IR range
Weight in kilogram and height in meters will be combined to report BMI in Kg/m^2
Time frame: up to 24 weeks
when obese T2D individuals will have significant improvement in BMI
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 27 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Sujeet Jha, MRCP principal investigator
Prinicipal Director, Institute of Endocrinology & Metabolism, Maxhealthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Calorie Diet in people with Type 2 Diabetes Mellitus in Obese, run by Max Healthcare Insititute Limited at 1 site in 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 4 inclusion and 3 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 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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. 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?
HbA1c in percentage (time frame: up to 24 weeks). The study lists 3 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 27 Apr 2020.