Is lactulose safe in patients with type 1 diabetes mellitus (T1DM)?

From the Guidelines

Lactulose is generally safe for use in patients with type 1 diabetes mellitus (T1DM) when used as directed, as it is not absorbed systemically and does not directly affect blood glucose levels. As an osmotic laxative, lactulose exerts its effect in the colon to promote peristalsis, and its use is approved by the FDA for the treatment of constipation at a dose of 10–20 g (15–30 mL or 1–2 packets) daily 1. The standard dosage for adults is 15-30 mL of lactulose solution taken orally once or twice daily, or as directed by a healthcare provider.

Key Considerations for T1DM Patients Using Lactulose

• T1DM patients using lactulose should monitor their hydration status closely, as the laxative effect can potentially lead to fluid loss, which can affect blood glucose levels and insulin sensitivity 1.
• Patients should also be aware that lactulose can cause gastrointestinal side effects such as bloating, gas, and abdominal cramps, which may affect appetite or food intake and indirectly impact blood glucose management 1.
• Although lactulose does not contain sugar, some commercial preparations may contain small amounts of lactose or galactose, which, although typically negligible in terms of blood glucose impact, may require caution in patients with severe lactose intolerance 1.

Diabetes Management and Lactulose Use

• The management of type 1 diabetes involves a comprehensive approach, including nutrition therapy, which should be individualized and preferably provided by a registered dietitian 1.
• Patients with T1DM should be educated on how to use carbohydrate counting and, in some cases, fat and protein gram estimation to determine mealtime insulin dosing, which can help improve glycemic control 1.
• The use of lactulose in patients with T1DM should be considered in the context of their overall diabetes management plan, with attention to potential interactions between lactulose and other aspects of their care, such as hydration status and gastrointestinal side effects 1.

Recommendations for Safe Use

• Patients with T1DM can safely use lactulose when used as directed, but they should be mindful of hydration, potential gastrointestinal side effects, and maintain regular blood glucose monitoring as part of their diabetes management routine 1.
• Healthcare providers should advise patients on the proper use of lactulose, including dosage and potential side effects, and monitor their response to treatment to minimize risks and optimize benefits 1.

From the FDA Drug Label

Since lactulose solution contains galactose (less than 1.6 g/15 mL) and lactose (less than 1.2 g/15 mL) it should be used with caution in diabetics.

• Lactulose should be used with caution in patients with diabetes, as it contains galactose and lactose.
• The FDA drug label does not provide specific information about the safety of lactulose in patients with type 1 diabetes mellitus (T1DM), but it advises caution in diabetics in general 2.
• Another drug label states that lactulose is contraindicated in patients who require a low galactose diet 2.

From the Research

Lactulose Safety in Patients with Type 1 Diabetes Mellitus (T1DM)

• There are no direct studies on the safety of lactulose in patients with T1DM, as the available evidence primarily focuses on its effects in healthy individuals or those with type 2 diabetes mellitus (T2DM) 3, 4, 5.
• A study on the treatment of T1DM with agents approved for T2DM discusses the use of various non-insulin therapies, but does not specifically address lactulose 6.
• The available studies on lactulose suggest that it does not significantly affect blood glucose levels in healthy individuals or those with T2DM, which may indicate its potential safety in patients with T1DM 3, 5.
• However, it is essential to note that patients with T1DM have different physiological and metabolic profiles compared to those with T2DM or healthy individuals, and therefore, the safety of lactulose in T1DM patients cannot be conclusively determined based on the available evidence.
• Further research is needed to investigate the safety and efficacy of lactulose in patients with T1DM.
• Lactulose is generally well-tolerated, with mild to moderate gastrointestinal side effects reported in some studies 7, 5.