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NCT03832725
Pathobiology of Remission of Type 2 Diabetes
NA trial testing High Protein (HP) weight loss diet in Newly Diagnosed Type 2 Diabetes in 100 participants. Status unknown.
31 July 2024
Quick facts
| Lead sponsor | University of Tennessee |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | other |
| Enrollment | 100 |
| Start date | 1 March 2018 |
| Primary completion | 31 July 2024 |
| Estimated completion | 31 July 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- High Protein (HP) weight loss diet
- High carbohydrate (HC) weight loss diet
Conditions studied
- Newly Diagnosed Type 2 Diabetes — all drugs for Newly Diagnosed Type 2 Diabetes →
- Obese — all drugs for Obese →
Sponsor
University of Tennessee
Who can join
Adults 20 to 50, any sex, with Newly Diagnosed Type 2 Diabetes or Obese. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
We propose to investigate effects of HP and HC weight loss diets in Newly Diagnosed T2DM (NT2DM) women and men for 6 months for remission of Type 2 Diabetes. Our long term goal is to establish a weight loss diet plan for remission of NT2DM which would be adaptable for use in physicians' clinics and metabolomics predictors for assessment of remission. The overall objective of this study is to determine if remission of NT2DM can be induced by dietary manipulation using a HP diet and the pathobiology of this remission. We hypothesize that NT2DM subjects will have remission to NGT on the HP diet when they are provided the food and daily menus for compliance. The rationale is the HP diet is palatable for subjects to continue after the 6 month study and stay in remission using diet plans we provide. We will compare the effects of the HP vs HC diet on remission. Specific aims of this study are to determine the effects of the HP and HC diets on NT2DM obese subjects in a 6 month feeding study and determine: (a)remission of NT2DM to Normal Glucose Tolerance(NGT), (b)weight loss, (c)improvements in metabolic markers, Cardiovascular Risk Factors(CVR), and inflammation markers, and epigenetic DNA methylation changes and pathways involved with remission and metabolomic markers to establish predictive markers of remission of NT2DM. We propose to use a non-pharmaceutical means (HP diet) for remission of T2DM and weight loss and determine the pathobiology involved in improvement in metabolic and CVRs by interrogating the samples with emerging technologies. The proposed research is significant because if we can demonstrate the HP diet cause remission of NT2DM to NGT along with other metabolic improvements, it would be a significant improvement in health risk and medical cost to subjects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03832725
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03832725 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Tennessee
- Last refreshed: 7 February 2019
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing