Low-carbohydrate diet in the treatment of type 2 diabetes mellitus (LoCaT): study protocol for a multicenter, randomized controlled trial.
Study Goal
The researchers aimed to compare the effects of a Low-Carbohydrate Diet (LCD) with canagliflozin on glucose control and other metabolic outcomes in patients with poorly controlled type 2 diabetes mellitus (T2DM).
Results Summary
The study found that LCD was compared to canagliflozin for its effects on hemoglobin A1C levels, time in range, and cost of antihyperglycemic agents, with additional exploratory outcomes including body composition and glycolipid metabolism. The abstract suggests the findings could optimize T2DM treatments, but specific results are not detailed.
Population
120 patients with poorly controlled type 2 diabetes mellitus.
Effective Dosage
Not specified
Duration
3 months
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
low-carbohydrate diet (LCD) | decrease | glucose control | patients with type 2 diabetes mellitus (T2DM) | - | effect on glucose control has been confirmed | #1 |
low-carbohydrate diet (LCD) | neutral | hemoglobin A1C levels | patients with poor-controlled T2DM | - | change | #2 |
canagliflozin | neutral | hemoglobin A1C levels | patients with poor-controlled T2DM | - | change | #3 |
low-carbohydrate diet (LCD) | neutral | time in range | patients with poor-controlled T2DM | - | outcomes | #4 |
canagliflozin | neutral | time in range | patients with poor-controlled T2DM | - | outcomes | #5 |
low-carbohydrate diet (LCD) | neutral | cost of antihyperglycemic agents | patients with poor-controlled T2DM | - | outcomes | #6 |
canagliflozin | neutral | cost of antihyperglycemic agents | patients with poor-controlled T2DM | - | outcomes | #7 |
BACKGROUND: Low-carbohydrate diet (LCD) is an emerging therapy for type 2 diabetes mellitus (T2DM). Although its effect on glucose control has been confirmed in previous clinical trials, most of those studies have focused on comparing calorie-restricted LCD to iso-caloric low-fat diets. In this study, we aim to compare the effects of LCD and canagliflozin, a sodium-glucose cotransporter 2 inhibitor, in patients with T2DM. METHODS: This is a multicenter, randomized controlled trial. We will recruit 120 patients with poor-controlled T2DM. Participants will be randomly divided into canagliflozin and LCD groups in a 1:1 ratio. The primary outcome is the change in hemoglobin A1C levels after the 3-month intervention. The secondary outcomes are the time in range and cost of antihyperglycemic agents. Exploratory outcomes include physical examination, body composition, glucose variability, appetite, glycolipid metabolism, liver lipid content, and urine glucose threshold. DISCUSSION: No previous study has compared an LCD with antihyperglycemic agents. In LoCaT, participants' metabolism will be assessed from multiple perspectives. It is believed that the finding obtained from this trial will optimize the treatments for patients with T2DM. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1900027592. Registered on November 20, 2019.