NCT03305939 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Abha Tewari, Devarsetty Praveen, Pavitra Madhira, Lakshmi K
Josyula, Rohina Joshi, Suresh B. Kokku, Vandana Garg, Ishita Rawal, Kanika Chopra, Nantu Chakma, Sabrina Ahmed, Arunasalam Pathmeswaran, Pavithra Godamunne, A. S. Lata, Rakesh Sahay, Tulsi Patel, Yashdeep Gupta, Nikhil Tandon, Aliya Naheed, Anushka Patel and Deksha Kapoor Feasibility of a Lifestyle Intervention Program for Prevention of Diabetes Among Women With Prior Gestational Diabetes Mellitus (LIVING Study) in South Asia: A Formative Research Study Front. Glob. Womens Health, 27 November 2020. https://doi.org/10.3389/fgwh.2020.587607
Gupta Y, Kapoor D, Josyula LK, Praveen D, Naheed A, Desai AK, Pathmeswaran A, de Silva HA, Lombard CB, Shamsul Alam D, Prabhakaran D, Teede HJ, Billot L, Bhatla N, Joshi R, Zoungas S, Jan S, Patel A, Tandon N
A lifestyle intervention programme for the prevention of Type 2 diabetes mellitus among South Asian women with gestational diabetes mellitus [LIVING study]: protocol for a randomized trial. Diabet Med. 2019 Feb;36(2):243-251. doi: 10.1111/dme.13850. Epub 2018 Nov 29.
Shanthosh J, Kapoor D, Josyula LK, Patel A, Gupta Y, Tandon N, Jan S, Teede HJ, Desai A, Joshi R, Praveen D
Lifestyle InterVention IN Gestational diabetes (LIVING) in India, Bangladesh and Sri Lanka: protocol for process evaluation of a randomised controlled trial. BMJ Open. 2020 Dec 13;10(12):e037774. doi: 10.1136/bmjopen-2020-037774.

A Lifestyle Intervention Program for the Prevention of Type 2 Diabetes Mellitus Among South Asian Women With Prior Gestational Diabetes Mellitus.

Clinical trial NCT03305939 - References