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NCT03225339: DIADEM-1

Diabetes Intervention Accentuating Diet and Enhancing Metabolism

Completed NA Last updated 8 April 2021
What this trial tests

NA trial testing Low Energy Diet in Diabetes Mellitus, Type 2 in 209 participants. Completed in 9 December 2020.

Timeline
16 July 2017
Primary endpoint
19 February 2020
9 December 2020

Quick facts

Lead sponsorWeill Cornell Medical College in Qatar
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment209
Start date16 July 2017
Primary completion19 February 2020
Estimated completion9 December 2020
Sites2 locations across Qatar

Drugs / interventions tested

Conditions studied

Sponsor

Weill Cornell Medical College in Qatar

Who can join

Adults 18 to 50, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Diabetes is one of the greatest challenges faced by healthcare services worldwide. It is associated with serious complications such as heart attacks, stroke, and peripheral artery disease as well as kidney disease, eye disease, and nerve dysfunction. Data from weight loss with bariatric surgery suggest that with the appropriate intervention, it should be possible to reverse diabetes and that the earlier the intervention occurs, the greater the chances of placing diabetes into remission. There is now a need to translate this knowledge into the medical care of younger patients with early diabetes who are overweight/obese. The aim of this study is to see if younger adult patients with overweight/obesity and type 2 diabetes who are participants in a programme incorporating a low energy diet and physical activity (lifestyle) will lower their weight, cardiovascular risk and improve their glycaemic control as compared to the usual care.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Effect of intensive lifestyle intervention on bodyweight and glycaemia in early type 2 diabetes (DIADEM-I): an open-label, parallel-group, randomised controlled trial.
    Taheri S, Zaghloul H, Chagoury O, Elhadad S, et al · · 2020 · cited 263× · PMID 32445735 · DOI 10.1016/s2213-8587(20)30117-0
  2. Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I): a randomised controlled trial to examine the impact of an intensive lifestyle intervention consisting of a low-energy diet and physical activity on body weight and metabolism in early type 2 diabetes mel
    Taheri S, Chagoury O, Zaghloul H, Elhadad S, et al · · 2018 · cited 12× · PMID 29784059 · DOI 10.1186/s13063-018-2660-1
  3. Clinical and metabolic characteristics of the Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I) randomised clinical trial cohort.
    Zaghloul H, Chagoury O, Elhadad S, Hayder Ahmed S, et al · · 2020 · cited 5× · PMID 33293319 · DOI 10.1136/bmjopen-2020-041386

Verify or expand the search:

Other trials of Low Energy Diet

Trials testing the same drug.

Other recruiting trials for Diabetes Mellitus, Type 2

Currently open trials in the same condition.

Other Weill Cornell Medical College in Qatar trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03225339.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing