Type-2 Diabetes Mellitus (T2DM)REMIT-PKNCT07912944
Lifestyle Medicine for Type 2 Diabetes Remission in Pakistan
A study testing Six-Pillar Lifestyle Medicine Programme in people with Type-2 Diabetes Mellitus (T2DM) and Diabetes Remission, run by Green International University at 2 sites in Pakistan.
Trial summary
This randomised controlled trial tests whether a structured six-pillar lifestyle medicine programme can lead to remission of type 2 diabetes in adults in Lahore, Pakistan. The programme combines a plant-predominant eating pattern without calorie counting, adapted to local Pakistani foods, with physical activity… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Type-2 Diabetes Mellitus (T2DM), Diabetes Remission
- What is being tested?
- Six-Pillar Lifestyle Medicine Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 2 sitesPakistan
- Study dates
- 26 Sep 2026to 27 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 30-65 years
- Confirmed diagnosis of type 2 diabetes
- Non-insulin-dependent, managed on oral glucose-lowering agents only
- Body mass index of 23 kg/m2 or above
- Diabetes duration since diagnosis of up to 8 years (shorter duration: under 5 years; longer duration: 5 to 8 years)
Who cannot join
- Age below 30 or above 65 years
- Insulin-dependent diabetes
- Diabetes duration exceeding 8 years
- Pregnancy or breastfeeding
- Major psychiatric illness likely to impair participation or follow up Severe renal or hepatic impairment
- Active malignancy
Show all 9Show fewer
- Bariatric surgery within the preceding 12 months
- Inability to provide informed consent
- Any other condition precluding safe participation in a structured lifestyle intervention.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites, 2 recruiting
- Recruiting
Diabetic Clinic 1
Lahore, Punjab Province, 54000
Mahboob Ahmad, MBBS, FCPS, 0092-332-490-5515, drmahboob100@hotmail.com
- Recruiting
Diabetic Clinic 2
Lahore, Punjab Province, 54000
Sajid Hameed, PhD, 0092-333-888-5539, doctorsajidhameed@gmail.com
About this study
Official title: EFFECTIVENESS OF A SIX-PILLAR LIFESTYLE MEDICINE INTERVENTION FOR TYPE 2 DIABETES REMISSION IN PAKISTANI CLINICAL SETTINGS: A RANDOMISED CONTROLLED TRIAL
This randomised controlled trial tests whether a structured six-pillar lifestyle medicine programme can lead to remission of type 2 diabetes in adults in Lahore, Pakistan. The programme combines a plant-predominant eating pattern without calorie counting, adapted to local Pakistani foods, with physical activity, sleep, stress regulation, social connection and reduced exposure to risky substances. Adults aged 30 to 65 years with type 2 diabetes of up to 8 years' duration, managed on oral medication only, are randomised to the programme or to usual care. The primary outcome is remission at 6 months, defined as HbA1c below 6.5% sustained for at least three months without glucose-lowering medication.
Read the detailed description
Parallel-group, stratified, open-label randomised controlled trial at two clinical sites in Lahore, Pakistan. Participants are randomised 1:1 within four strata (site and diabetes duration band: under 5 years, 5 to 8 years) using permuted blocks and sealed, opaque, sequentially numbered envelopes. The intervention arm receives individual sessions delivered in Urdu at baseline, weeks 2, 4, 8 and 12, and then monthly through month 6. Medication changes are made only by the treating physician under a prespecified titration protocol, with the highest hypoglycaemia-risk agents withdrawn first and metformin retained longest. The usual-care arm continues routine medical management. Formal assessments occur at baseline, 3 months and 6 months (primary endpoint), with an exploratory, non-powered follow-up at 9 months. Analysis follows the intention-to-treat principle. Target sample size is 178 participants (89 per arm), allowing for 20% attrition, with 80% power at a two-sided alpha of 0.05.
- Being tested
- Six-Pillar Lifestyle Medicine Programme, usual care treatment
- Keywords
- Lifestyle medicine, diabetes remission, plant-predominant diet, Pakistan, South Asian, Randomised controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Six-Pillar Lifestyle Medicine ProgrammeBehavioural
A structured six-pillar lifestyle medicine programme delivered in Urdu over 6 months through brief individual sessions, with physician-led titration of glucose-lowering medication under a prespecified protocol.
usual care treatmentOther
Routine medical management for type 2 diabetes according to the standard practice of the treating clinical team, which may include routine physician follow-up, medication management, clinically indicated laboratory tests, and standard diabetes education or lifestyle advice ordinarily provided in routine care.
| Study group | Role | What they receive |
|---|---|---|
| Six-Pillar Lifestyle Medicine Programme | Experimental | Participants receive a structured six-pillar lifestyle medicine programme delivered in Urdu, by the researcher . The six pillars are nutrition (a plant-predominant eating pattern without calorie counting, adapted to local Pakistani foods), physical activity, sleep, stress regulation, reduced exposure to risky substances, and social connection. Brief individual sessions are held at baseline, weeks 2, 4, 8 and 12, then monthly through month 6. The treating physician makes all medication decisions, using a prespecified protocol to review and reduce glucose-lowering medication as glycaemic control improves. Receives: Behavioral: Six-Pillar Lifestyle Medicine Programme |
| Usual Care | Active comparator | Participants continue routine medical management for type 2 diabetes according to the standard practice of the treating clinical team. This may include routine physician follow-up, medication management, clinically indicated laboratory tests, and any standard diabetes education or lifestyle advice ordinarily provided in routine care. They do not receive the structured six-pillar programme delivered by the research team. Medication changes follow the treating physician's standard clinical judgement. Receives: Other: usual care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving type 2 diabetes remission
Remission is defined per the ADA/EASD 2021 consensus statement as HbA1c below 6.5% sustained for at least three months without glucose-lowering medication. It is confirmed by laboratory-measured HbA1c.
Measured: 6 Months
Secondary outcomes (1)
Change in HbA1c
Measured: 3Monts and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start26 Sep 2026
- Primary completion27 Apr 2027 (estimated)
- Study completion27 Jul 2027 (estimated)
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 (T2DM)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Green International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadaf Ayyaz, Green International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912944
- Sponsor's protocol ID
- REMIT-PK
- Other IDs
- GIU/REC/26-74
- Acronym
- REMIT-PK
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS OF A SIX-PILLAR LIFESTYLE MEDICINE INTERVENTION FOR TYPE 2 DIABETES REMISSION IN PAKISTANI CLINICAL SETTINGS: A RANDOMISED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT07912944
- Acronym / sponsor ID
- REMIT-PK / REMIT-PK
- Keywords
- Lifestyle medicine, diabetes remission, plant-predominant diet, Pakistan, South Asian, Randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Green International UniversityUniversity, hospital or other
- Study start
- 26 Sep 2026 (actual)
- Primary completion
- 27 Apr 2027 (estimated)
- Study completion
- 27 Jul 2027 (estimated)
- First posted
- 3 Nov 2026 (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 randomised controlled trial tests whether a structured six-pillar lifestyle medicine programme can lead to remission of type 2 diabetes in adults in Lahore, Pakistan. The programme combines a plant-predominant eating pattern without calorie counting, adapted to local Pakistani foods, with physical activity, sleep, stress regulation, social connection and reduced exposure to risky substances. Adults aged 30 to 65 years with type 2 diabetes of up to 8 years' duration, managed on oral medication only, are randomised to the programme or to usual care. The primary outcome is remission at 6 months, defined as HbA1c below 6.5% sustained for at least three months without glucose-lowering medication.
Detailed description
Parallel-group, stratified, open-label randomised controlled trial at two clinical sites in Lahore, Pakistan. Participants are randomised 1:1 within four strata (site and diabetes duration band: under 5 years, 5 to 8 years) using permuted blocks and sealed, opaque, sequentially numbered envelopes. The intervention arm receives individual sessions delivered in Urdu at baseline, weeks 2, 4, 8 and 12, and then monthly through month 6. Medication changes are made only by the treating physician under a prespecified titration protocol, with the highest hypoglycaemia-risk agents withdrawn first and metformin retained longest. The usual-care arm continues routine medical management. Formal assessments occur at baseline, 3 months and 6 months (primary endpoint), with an exploratory, non-powered follow-up at 9 months. Analysis follows the intention-to-treat principle. Target sample size is 178 participants (89 per arm), allowing for 20% attrition, with 80% power at a two-sided alpha of 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Six-Pillar Lifestyle Medicine Programme | Experimental | Behavioral: Six-Pillar Lifestyle Medicine ProgrammeParticipants receive a structured six-pillar lifestyle medicine programme delivered in Urdu, by the researcher . The six pillars are nutrition (a plant-predominant eating pattern without calorie counting, adapted to local Pakistani foods), physical activity, sleep, stress regulation, reduced exposure to risky substances, and social connection. Brief individual sessions are held at baseline, weeks 2, 4, 8 and 12, then monthly through month 6. The treating physician makes all medication decisions, using a prespecified protocol to review and reduce glucose-lowering medication as glycaemic control improves. |
| Usual Care | Active comparator | Other: usual care treatmentParticipants continue routine medical management for type 2 diabetes according to the standard practice of the treating clinical team. This may include routine physician follow-up, medication management, clinically indicated laboratory tests, and any standard diabetes education or lifestyle advice ordinarily provided in routine care. They do not receive the structured six-pillar programme delivered by the research team. Medication changes follow the treating physician's standard clinical judgement. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 30-65 years
- Confirmed diagnosis of type 2 diabetes
- Non-insulin-dependent, managed on oral glucose-lowering agents only
- Body mass index of 23 kg/m2 or above
- Diabetes duration since diagnosis of up to 8 years (shorter duration: under 5 years; longer duration: 5 to 8 years)
Key exclusion criteria (9 listed)
- Age below 30 or above 65 years
- Insulin-dependent diabetes
- Diabetes duration exceeding 8 years
- Pregnancy or breastfeeding
- Major psychiatric illness likely to impair participation or follow up Severe renal or hepatic impairment
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 |
|---|---|---|
| Six-Pillar Lifestyle Medicine ProgrammeA structured six-pillar lifestyle medicine programme delivered in Urdu over 6 months through brief individual sessions, with physician-led titration of glucose-lowering medication under a prespecified protocol. | Behavioural | Six-Pillar Lifestyle Medicine Programme |
| usual care treatmentRoutine medical management for type 2 diabetes according to the standard practice of the treating clinical team, which may include routine physician follow-up, medication management, clinically indicated laboratory tests, and standard diabetes education or lifestyle advice ordinarily provided in routine care. | Other | Usual Care |
Primary outcome
Proportion of participants achieving type 2 diabetes remission
Time frame: 6 Months
Remission is defined per the ADA/EASD 2021 consensus statement as HbA1c below 6.5% sustained for at least three months without glucose-lowering medication. It is confirmed by laboratory-measured HbA1c.
1 secondary outcome
Change in HbA1c
Time frame: 3Monts and 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Six-Pillar Lifestyle Medicine Programme in people with Type-2 Diabetes Mellitus (T2DM) and Diabetes Remission, run by Green International University at 2 sites in Pakistan.
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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sadaf Ayyaz, Pharm-D (0092-333 4758491, sadafayyaz.sa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving type 2 diabetes remission (time frame: 6 Months). 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 3 Nov 2026.