An interventional study of Six-Pillar Lifestyle Medicine Programme and usual care treatment in Type-2 Diabetes Mellitus (T2DM) and Diabetes Remission, sponsored by Green International University. Recruiting at 2 sites in Pakistan. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Green International University · Not applicable, Interventional, and Treatment
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.
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made only by the treating physician under a prespecified titration protocol, with the highest hypoglycaemia-risk agents withdrawn first and metformin retained longest.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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 178 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Green International University is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Six-Pillar Lifestyle Medicine Programme
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.
Other: usual care treatment
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.
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.
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.
Time frame: 6 Months
Change in HbA1c
Time frame: 3Monts and 6 Months
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Apr 2027, 7 months after the start.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 7 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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